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A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030143
Recruitment Status : Completed
First Posted : July 23, 2019
Results First Posted : November 18, 2023
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Bipolar I Disorder
Intervention Drug: Aripiprazole
Enrollment 266
Recruitment Details Participants were enrolled in the study at 16 investigational sites in the United States from 01 August 2019 to 08 July 2020.
Pre-assignment Details  
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description Participants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks. Participants with schizophrenia or bipolar I disorder received aripiprazole intra-muscularly (IM) 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Period Title: Overall Study
Started 132 134
Safety Sample [1] 132 134
Efficacy Sample [2] 132 134
Completed 102 92
Not Completed 30 42
Reason Not Completed
Adverse Event             5             10
Lost to Follow-up             3             7
Protocol Deviation             2             2
Withdrawal by Subject             16             18
Physician Decision             1             1
Due to Covid-19             2             3
Not Due to Covid-19             1             1
[1]
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
[2]
Efficacy sample included all randomized participants who received at least 1 dose of aripiprazole injection and had at least 1 efficacy assessment.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Total
Hide Arm/Group Description Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks. Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks. Total of all reporting groups
Overall Number of Baseline Participants 132 134 266
Hide Baseline Analysis Population Description
Randomized sample consisted of all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 134 participants 266 participants
47.8  (10.8) 46.8  (11.7) 47.3  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 134 participants 266 participants
Female
42
  31.8%
48
  35.8%
90
  33.8%
Male
90
  68.2%
86
  64.2%
176
  66.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 134 participants 266 participants
Hispanic or Latino
12
   9.1%
11
   8.2%
23
   8.6%
Not Hispanic or Latino
119
  90.2%
122
  91.0%
241
  90.6%
Unknown or Not Reported
1
   0.8%
1
   0.7%
2
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 132 participants 134 participants 266 participants
White
29
  22.0%
33
  24.6%
62
  23.3%
Black or African American
99
  75.0%
95
  70.9%
194
  72.9%
Asian
3
   2.3%
4
   3.0%
7
   2.6%
Other
1
   0.8%
2
   1.5%
3
   1.1%
1.Primary Outcome
Title Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP.
Time Frame From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 132 134
Measure Type: Count of Participants
Unit of Measure: Participants
94
  71.2%
95
  70.9%
2.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities
Hide Description Potentially clinically significant vital sign abnormalities included: heart rate supine (high: >120 beats per minute [BPM] and increase >=15 BPM; low: <50 BPM and decrease >=15 BPM), systolic blood pressure supine (high >180 (millimetres of mercury [mmHg] and increase >=20 mmHg); low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure supine (high: >105 mmHg and increase >=15 mmHg; low: <50 mmHg and decrease >=15 mmHg), heart rate standing (high: >120 BPM and increase >=15 BPM), systolic blood pressure standing (high: >180 mmHg and increase >= 20 mmHg; low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure standing (high: >105 mmHg and increase >=15 mmHg), weight in kilograms (kg) (high: increase >=7%; low: decrease >=7%), temperature (high: >=37.8 degree celsius [°C] and increase >=1.1°C), orthostatic hypotension (low: >=20 mmHg decrease in systolic blood pressure and >=25 BPM increase in heart rate from supine to standing.
Time Frame From first dose of study drug up to Day 225
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 131 133
Measure Type: Count of Participants
Unit of Measure: Participants
Heart Rate Supine: Low Number Analyzed 131 participants 133 participants
0
   0.0%
1
   0.8%
Heart Rate Supine: High Number Analyzed 131 participants 133 participants
2
   1.5%
1
   0.8%
Systolic Blood Pressure Supine: Low Number Analyzed 131 participants 133 participants
1
   0.8%
2
   1.5%
Systolic Blood Pressure Supine: High Number Analyzed 131 participants 133 participants
0
   0.0%
1
   0.8%
Diastolic Blood Pressure Supine: Low Number Analyzed 131 participants 133 participants
1
   0.8%
1
   0.8%
Diastolic Blood Pressure Supine: High Number Analyzed 131 participants 133 participants
1
   0.8%
1
   0.8%
Heart Rate Standing: High Number Analyzed 131 participants 133 participants
4
   3.1%
6
   4.5%
Systolic Blood Pressure Standing: Low Number Analyzed 131 participants 133 participants
1
   0.8%
4
   3.0%
Systolic Blood Pressure Standing: High Number Analyzed 131 participants 133 participants
0
   0.0%
2
   1.5%
Diastolic Blood Pressure Standing: High Number Analyzed 131 participants 133 participants
2
   1.5%
3
   2.3%
Weight: Low Number Analyzed 128 participants 126 participants
12
   9.4%
11
   8.7%
Weight: High Number Analyzed 128 participants 126 participants
52
  40.6%
54
  42.9%
Temperature: High Number Analyzed 131 participants 133 participants
4
   3.1%
4
   3.0%
Orthostatic Hypotension: Low Number Analyzed 131 participants 133 participants
2
   1.5%
2
   1.5%
3.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities
Hide Description Potentially clinically significant ECG abnormalities included rate: bradycardia (vent <=50 BPM] and decrease >=15 BPM); rhythm: sinus bradycardia (<= 50 BPM and decrease >= 15 BPM and no current diagnosis of atrial fibrillation, atrial flutter, or other rhythm abnormality); supraventricular premature beat (not present at baseline and present post baseline); ventricular premature beat (not present at baseline and present post baseline); conduction: right bundle branch block (not present at baseline and present post baseline); ST/T morphology: myocardial ischemia and symmetrical T-wave inversion (not present at baseline and present post baseline), QTcB, QTcF, and QTcN (>=450 milliseconds [msec] and >= 10% increase).
Time Frame From first dose of study drug up to Day 225
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 130 131
Measure Type: Count of Participants
Unit of Measure: Participants
Bradycardia
0
   0.0%
2
   1.5%
Sinus Bradycardia
0
   0.0%
2
   1.5%
Supraventricular Premature Beat
13
  10.0%
10
   7.6%
Ventricular Premature Beat
17
  13.1%
12
   9.2%
Right Bundle Branch Block
1
   0.8%
0
   0.0%
Myocardial Ischemia
3
   2.3%
7
   5.3%
Symmetrical T-Wave Inversion
12
   9.2%
12
   9.2%
QTcB
1
   0.8%
1
   0.8%
QTcF
0
   0.0%
1
   0.8%
QTcN
0
   0.0%
1
   0.8%
4.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities
Hide Description Potentially clinically relevant laboratory abnormalities included: In units per liter [U/L] (alanine aminotransferase: male[M]/female[F] >=3 x upper limit of normal (ULN); aspartate aminotransferase: M/F >= 3 x ULN; creatine kinase: M/F >= 3 x ULN); in milligrams per deciliter (mg/dL) (creatinine: M/F >= 2.0; glucose: M/F >= 200; urate: M >=10.5, F >=8.5); potassium [milliequivalents per liter (mEq/L)]: M/F >=5.5, in percentage (%) (eosinophils/leukocytes: M/F>=10%, hematocrit: M<=37%/F<=32% and 3 point decrease from baseline); hemoglobin (grams per deciliter [g/dL]): M<=11.5/F<=9.5; leukocytes [10^9 per liter (/L)]: M/F<=2.8 x 10^3 per microliters (/uL); platelets (10^9/L): M/F>=700 x 10^3/uL; glucose, urine and protein, urine: increase of >=2 units; and prolactin (nanograms per milliliter [ng/mL]: M/F > 1 x ULN.
Time Frame From first dose of study drug up to Day 225
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 129 126
Measure Type: Count of Participants
Unit of Measure: Participants
High Alanine Aminotransferase (U/L) Number Analyzed 128 participants 126 participants
1
   0.8%
2
   1.6%
High Aspartate Aminotransferase (U/L) Number Analyzed 128 participants 126 participants
0
   0.0%
2
   1.6%
High Creatine Kinase (U/L) Number Analyzed 128 participants 126 participants
12
   9.4%
1
   0.8%
High Creatinine (mg/dL) Number Analyzed 128 participants 126 participants
2
   1.6%
1
   0.8%
High Glucose (mg/dL) Number Analyzed 128 participants 126 participants
7
   5.5%
3
   2.4%
High Potassium (mEq/L) Number Analyzed 128 participants 126 participants
5
   3.9%
4
   3.2%
High Urate (mg/dL) Number Analyzed 128 participants 126 participants
2
   1.6%
0
   0.0%
High Eosinophils/Leukocytes (%) Number Analyzed 129 participants 126 participants
2
   1.6%
0
   0.0%
Low Hematocrit (%) Number Analyzed 129 participants 126 participants
7
   5.4%
8
   6.3%
Low Hemoglobin (g/dL) Number Analyzed 129 participants 126 participants
4
   3.1%
9
   7.1%
Low Leukocytes (10^9/L) Number Analyzed 129 participants 126 participants
0
   0.0%
3
   2.4%
High Platelets (10^9/L) Number Analyzed 129 participants 126 participants
0
   0.0%
1
   0.8%
High Glucose, Urine Number Analyzed 128 participants 126 participants
5
   3.9%
6
   4.8%
High Protein, Urine Number Analyzed 128 participants 126 participants
1
   0.8%
2
   1.6%
High Prolactin (ng/mL) Number Analyzed 123 participants 118 participants
2
   1.6%
4
   3.4%
5.Primary Outcome
Title Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score
Hide Description The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 132 134
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 132 participants 134 participants
0.2  (0.6) 0.2  (0.4)
Change From Baseline at Week 32 Number Analyzed 131 participants 133 participants
-0.0  (0.7) 0.1  (0.6)
6.Primary Outcome
Title Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score
Hide Description The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). AIMS movement score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 132 134
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 132 participants 134 participants
0.1  (1.0) 0.1  (0.7)
Change from Baseline at Week 32 Number Analyzed 131 participants 133 participants
0.0  (0.5) -0.1  (0.6)
7.Primary Outcome
Title Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score
Hide Description The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. Total BARS score ranges from 0 to 14 where lower scores indicate less symptoms and negative change from baseline indicate less symptoms.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 132 134
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 132 participants 134 participants
0.1  (0.3) 0.1  (0.3)
Change from Baseline at Week 32 Number Analyzed 131 participants 133 participants
0.1  (0.6) 0.1  (0.4)
8.Primary Outcome
Title Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg
Hide Description Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful).
Time Frame Day 1 (First injection) to Day 169 (Last injection)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: score on a scale
First Injection: Predose Number Analyzed 131 participants
1.0  (1.29)
First Injection: Post dose Number Analyzed 130 participants
3.7  (9.09)
Second Injection: Predose Number Analyzed 113 participants
1.0  (2.32)
Second Injection: Post dose Number Analyzed 113 participants
1.4  (2.78)
Third Injection: Predose Number Analyzed 109 participants
1.0  (2.58)
Third Injection: Post dose Number Analyzed 105 participants
2.0  (6.01)
Fourth Injection: Predose Number Analyzed 103 participants
0.8  (1.02)
Fourth Injection: Post dose Number Analyzed 102 participants
1.4  (4.38)
Last Injection: Predose Number Analyzed 132 participants
0.8  (1.03)
Last Injection: Post dose Number Analyzed 130 participants
1.4  (3.98)
9.Primary Outcome
Title VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg
Hide Description Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful).
Time Frame Day 1 (First injection) to Day 197 (Last injection)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. Participants whose VAS scores were analyzed for pain perception, are reported in this outcome measure, and may differ from participants who were assessed by Investigator for pain on 4-point scale.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 134
Mean (Standard Deviation)
Unit of Measure: score on a scale
First Injection: Predose Number Analyzed 134 participants
1.6  (2.37)
First Injection: Post dose Number Analyzed 130 participants
3.0  (5.28)
Second Injection: Predose Number Analyzed 117 participants
1.5  (2.66)
Second Injection: Post dose Number Analyzed 112 participants
1.6  (3.09)
Third Injection: Predose Number Analyzed 107 participants
0.8  (1.10)
Third Injection: Post dose Number Analyzed 103 participants
1.2  (2.09)
Fourth Injection: Predose Number Analyzed 103 participants
0.7  (0.79)
Fourth Injection: Post dose Number Analyzed 102 participants
1.1  (2.39)
Fifth Injection: Predose Number Analyzed 99 participants
0.7  (0.82)
Fifth Injection: Post dose Number Analyzed 99 participants
0.8  (1.12)
Sixth Injection: Predose Number Analyzed 97 participants
0.8  (1.11)
Sixth Injection: Post dose Number Analyzed 96 participants
0.8  (1.20)
Seventh Injection: Predose Number Analyzed 92 participants
0.6  (0.77)
Seventh Injection: Post dose Number Analyzed 90 participants
1.0  (2.30)
Eighth Injection: Predose Number Analyzed 89 participants
0.6  (0.69)
Eighth Injection: Post dose Number Analyzed 89 participants
0.8  (0.85)
Last Injection: Predose Number Analyzed 132 participants
0.9  (1.00)
Last Injection: Post dose Number Analyzed 131 participants
1.3  (2.62)
10.Primary Outcome
Title Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection
Hide Description Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant.
Time Frame Day 1 (First injection) to Day 169 (Last injection)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 131
Measure Type: Count of Participants
Unit of Measure: Participants
First Injection: Mild Pain Number Analyzed 130 participants
11
   8.5%
Second Injection: Mild Pain Number Analyzed 114 participants
2
   1.8%
Third Injection: Mild Pain Number Analyzed 108 participants
5
   4.6%
Fourth Injection: Mild Pain Number Analyzed 102 participants
5
   4.9%
Last injection: Mild Pain Number Analyzed 131 participants
5
   3.8%
First injection: Mild Redness Number Analyzed 130 participants
3
   2.3%
Third injection: Mild Redness Number Analyzed 108 participants
1
   0.9%
Last injection: Mild Redness Number Analyzed 131 participants
1
   0.8%
11.Primary Outcome
Title Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection
Hide Description Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant.
Time Frame Day 1 (First injection) to Day 197 (Last injection)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. Participants whose injection-site reactions were assessed by the investigator, are reported in this outcome measure, and may differ from participants whose VAS scores were assessed for pain.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 134
Measure Type: Count of Participants
Unit of Measure: Participants
First Injection: Mild Pain Number Analyzed 131 participants
7
   5.3%
Second Injection: Mild Pain Number Analyzed 116 participants
3
   2.6%
Third Injection: Mild Pain Number Analyzed 109 participants
7
   6.4%
Fourth Injection: Mild Pain Number Analyzed 105 participants
1
   1.0%
Fifth Injection: Mild Pain Number Analyzed 101 participants
3
   3.0%
Seventh Injection: Mild Pain Number Analyzed 94 participants
1
   1.1%
Eighth Injection: Mild Pain Number Analyzed 90 participants
1
   1.1%
Last injection: Mild Pain Number Analyzed 134 participants
3
   2.2%
First injection: Mild Redness Number Analyzed 132 participants
1
   0.8%
Second injection: Mild Redness Number Analyzed 116 participants
3
   2.6%
12.Primary Outcome
Title Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior. Suicidality was defined as reporting any suicidal ideation or behavior.
Time Frame Baseline to Day 225
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 130 132
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.1%
4
   3.0%
13.Primary Outcome
Title Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose
Hide Description [Not Specified]
Time Frame Day 225
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics (PK) sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure (OM) analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: ng/mL (nanogram per milliliter)
250  (128)
14.Primary Outcome
Title Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose
Hide Description [Not Specified]
Time Frame Day 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: ng/mL
257  (162)
15.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg
Hide Description [Not Specified]
Time Frame Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197 (predose and 4, 8, 12 hours post dose), 198, 199, 201, 204, 206, 209, 211, 214, 218, 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
AUC0-28 After Seventh Dose (Day 169) Number Analyzed 33 participants
7760  (4300)
AUC0-28 After Eighth Dose (Day 197) Number Analyzed 32 participants
7840  (5170)
16.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
14700  (7460)
17.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax After First Dose (Day 1) Number Analyzed 37 participants
286  (203)
Cmax After Fourth Dose (Day 169) Number Analyzed 34 participants
342  (157)
18.Secondary Outcome
Title Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: days
Tmax After First Dose (Day 1) Number Analyzed 37 participants
8.58
(3.92 to 55.9)
Tmax After Fourth Dose (Day 169) Number Analyzed 34 participants
28.0
(0.930 to 49.0)
19.Secondary Outcome
Title AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Days 1 (predose and 4, 8, 12 hours post-dose), 2, 3, 5, 8, 10, 13, 15, 18, 22, 29, 36, 43, 50 and 57 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
9180  (4940)
20.Secondary Outcome
Title Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Predose on Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: ng/mL
165  (91.7)
21.Secondary Outcome
Title AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Days 169 (predose and 4, 8, 12 hours postdose), 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
7190  (3470)
22.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Days 204, 211, 218, and 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
7500  (4200)
23.Secondary Outcome
Title Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg
Hide Description PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following fourth dose.
Time Frame Days 169 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: percentage fluctuation
63.4  (25.1)
24.Secondary Outcome
Title Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg
Hide Description [Not Specified]
Time Frame Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax After First Dose (Day 1) Number Analyzed 35 participants
280  (123)
Cmax After Seventh Dose (Day 169) Number Analyzed 33 participants
339  (168)
Cmax After Eighth Dose (Day 197) Number Analyzed 32 participants
344  (212)
25.Secondary Outcome
Title Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg
Hide Description [Not Specified]
Time Frame Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 35
Median (Full Range)
Unit of Measure: days
Tmax After First Dose (Day 1) Number Analyzed 35 participants
9.04
(3.83 to 27.9)
Tmax After Seventh Dose (Day 169) Number Analyzed 34 participants
6.97
(1.05 to 28.0)
Tmax After Eighth Dose (Day 197) Number Analyzed 34 participants
4.07
(0 to 28.0)
26.Secondary Outcome
Title AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg
Hide Description [Not Specified]
Time Frame Days 1 (predose and 4, 8, and 12 hours postdose), 2, 3, 5, 8, 10, 13, 15, 18, 22 and 29 (predose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
5030  (2580)
27.Secondary Outcome
Title Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg
Hide Description [Not Specified]
Time Frame Predose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: ng/mL
112  (82.9)
28.Secondary Outcome
Title PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg
Hide Description PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following eighth dose.
Time Frame Days 197 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose),198, 199, 201, 204, 206, 209, 211, 214, 218, 225
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: percentage fluctuation
48.3  (19.0)
29.Secondary Outcome
Title Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg
Hide Description [Not Specified]
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: ng/mL
221  (178)
30.Secondary Outcome
Title Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg
Hide Description [Not Specified]
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.
Arm/Group Title Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: ng/mL
229  (121)
31.Secondary Outcome
Title Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worse condition. The PANSS was assessed for schizophrenia participants only.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia Aripiprazole IM Depot 400 mg: Schizophrenia
Hide Arm/Group Description:
Participants with schizophrenia received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 89 85
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.6  (11.7) -1.7  (8.5)
32.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score
Hide Description The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The cumulative score range is 0-7. A higher score on the CGI-S represents a higher severity of disease. The CGI-S scale was assessed for schizophrenia participants only.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia Aripiprazole IM Depot 400 mg: Schizophrenia
Hide Arm/Group Description:
Participants with schizophrenia received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 89 85
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.3  (0.6) -0.1  (0.7)
33.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score
Hide Description The CGI-I scale is a clinician rated scale which assesses the improvement of illness for each participant. To assess CGI-I, the rater or investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared with the participant's condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Scores range from 0 to 7. Higher scores indicate worse condition.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 123 117
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.4  (1.1) 3.5  (1.1)
34.Secondary Outcome
Title Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score
Hide Description The participant's feeling of their own well-being was assessed using the 20-question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of well-being while receiving antipsychotic medication. The questionnaire consisted of 20 items (10 positive and 10 negative statements) and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', the response choices and scoring is not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, and very much = 6. For items marked with a '- ', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 1 (none) to 6 (severe), and total score ranged from 20 to 120, with higher scores indicating stronger subjective feeling
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description:
Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 125 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.2  (15.8) 0.5  (18.2)
35.Secondary Outcome
Title Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a diagnostic questionnaire used by clinician to assess the participant's severity of depression. This scale consists of 10 items each with 7 defined grades of severity on 0 to 6 scale (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). MADRS total score is sum of 10 individual item scores ranging from 0-60 categorized as: 0 to 6: normal/symptoms absent, 7 to 19: mild depression, 20 to 34: moderate depression, and 35 to 60: severe depression. Higher score indicates more depressive symptoms. The MADRS was assessed for bipolar I disorder participants only.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Bipolar I Disorder Aripiprazole IM Depot 400 mg: Bipolar I Disorder
Hide Arm/Group Description:
Participants with bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.5  (9.1) -3.3  (12.5)
36.Secondary Outcome
Title Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
Hide Description The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score range is from 0 to 60 and the higher score represent a worse outcome. The YMRS was assessed for bipolar I disorder participants only.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Bipolar I Disorder Aripiprazole IM Depot 400 mg: Bipolar I Disorder
Hide Arm/Group Description:
Participants with bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.9  (7.1) -4.7  (7.7)
37.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score
Hide Description The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale ranging from 1 (normal, not ill) to 7 (very severely ill). A negative change score signifies improvement. The CGI-BP was assessed for bipolar I disorder participants only.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.
Arm/Group Title Aripiprazole 2M LAI 960 mg: Bipolar I Disorder Aripiprazole IM Depot 400 mg: Bipolar I Disorder
Hide Arm/Group Description:
Participants with bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Participants with bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Number of Participants Analyzed 39 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.2  (1.0) -0.6  (1.2)
Time Frame From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)
Adverse Event Reporting Description Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
 
Arm/Group Title Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Hide Arm/Group Description Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks. Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
All-Cause Mortality
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Affected / at Risk (%) Affected / at Risk (%)
Total   1/132 (0.76%)   0/134 (0.00%) 
Hide Serious Adverse Events
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Affected / at Risk (%) Affected / at Risk (%)
Total   6/132 (4.55%)   8/134 (5.97%) 
Cardiac disorders     
Cardiac Arrest † 1  1/132 (0.76%)  0/134 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute † 1  0/132 (0.00%)  1/134 (0.75%) 
Infections and infestations     
Cellulitis † 1  1/132 (0.76%)  0/134 (0.00%) 
Septic Shock † 1  0/132 (0.00%)  1/134 (0.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of Colon † 1  0/132 (0.00%)  1/134 (0.75%) 
Nervous system disorders     
Akathisia † 1  1/132 (0.76%)  1/134 (0.75%) 
Psychiatric disorders     
Depression † 1  0/132 (0.00%)  1/134 (0.75%) 
Depressive Symptom † 1  0/132 (0.00%)  1/134 (0.75%) 
Hallucination, auditory † 1  2/132 (1.52%)  0/134 (0.00%) 
Psychotic Disorder † 1  1/132 (0.76%)  1/134 (0.75%) 
Schizophrenia † 1  0/132 (0.00%)  1/134 (0.75%) 
Suicide Attempt † 1  0/132 (0.00%)  1/134 (0.75%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder
Affected / at Risk (%) Affected / at Risk (%)
Total   92/132 (69.70%)   92/134 (68.66%) 
Blood and lymphatic system disorders     
Lymphadenopathy † 1  1/132 (0.76%)  0/134 (0.00%) 
Neutropenia † 1  0/132 (0.00%)  1/134 (0.75%) 
Eye disorders     
Photophobia † 1  0/132 (0.00%)  1/134 (0.75%) 
Vision Blurred † 1  1/132 (0.76%)  2/134 (1.49%) 
Gastrointestinal disorders     
Abdominal Discomfort † 1  3/132 (2.27%)  5/134 (3.73%) 
Constipation † 1  8/132 (6.06%)  8/134 (5.97%) 
Dental Caries † 1  1/132 (0.76%)  0/134 (0.00%) 
Dental Discomfort † 1  0/132 (0.00%)  1/134 (0.75%) 
Diarrhoea † 1  6/132 (4.55%)  1/134 (0.75%) 
Dry Mouth † 1  0/132 (0.00%)  1/134 (0.75%) 
Dyspepsia † 1  3/132 (2.27%)  3/134 (2.24%) 
Flatulence † 1  0/132 (0.00%)  1/134 (0.75%) 
Food Poisoning † 1  1/132 (0.76%)  0/134 (0.00%) 
Gastrooesophageal Reflux Disease † 1  0/132 (0.00%)  2/134 (1.49%) 
Gingival Swelling † 1  0/132 (0.00%)  1/134 (0.75%) 
Nausea † 1  4/132 (3.03%)  1/134 (0.75%) 
Salivary Hypersecretion † 1  2/132 (1.52%)  1/134 (0.75%) 
Toothache † 1  2/132 (1.52%)  10/134 (7.46%) 
Vomiting † 1  3/132 (2.27%)  1/134 (0.75%) 
General disorders     
Fatigue † 1  1/132 (0.76%)  0/134 (0.00%) 
Influenza Like Illness † 1  3/132 (2.27%)  2/134 (1.49%) 
Injection Site Discomfort † 1  1/132 (0.76%)  0/134 (0.00%) 
Injection Site Mass † 1  1/132 (0.76%)  0/134 (0.00%) 
Injection Site Pain † 1  24/132 (18.18%)  12/134 (8.96%) 
Oedema Peripheral † 1  1/132 (0.76%)  1/134 (0.75%) 
Infections and infestations     
Bacterial Vaginosis † 1  1/132 (0.76%)  0/134 (0.00%) 
Body Tinea † 1  1/132 (0.76%)  0/134 (0.00%) 
Bronchitis † 1  1/132 (0.76%)  1/134 (0.75%) 
Cellulitis † 1  2/132 (1.52%)  0/134 (0.00%) 
Gastroenteritis † 1  1/132 (0.76%)  0/134 (0.00%) 
Gastroenteritis Viral † 1  2/132 (1.52%)  1/134 (0.75%) 
Infected Bite † 1  0/132 (0.00%)  1/134 (0.75%) 
Influenza † 1  1/132 (0.76%)  1/134 (0.75%) 
Localised Infection † 1  0/132 (0.00%)  1/134 (0.75%) 
Nasopharyngitis † 1  2/132 (1.52%)  4/134 (2.99%) 
Periodontitis † 1  0/132 (0.00%)  1/134 (0.75%) 
Pustule † 1  0/132 (0.00%)  1/134 (0.75%) 
Sinusitis † 1  3/132 (2.27%)  2/134 (1.49%) 
Tooth Abscess † 1  2/132 (1.52%)  0/134 (0.00%) 
Upper Respiratory Tract Infection † 1  6/132 (4.55%)  2/134 (1.49%) 
Urinary Tract Infection † 1  1/132 (0.76%)  3/134 (2.24%) 
Viral Upper Respiratory Tract Infection † 1  1/132 (0.76%)  0/134 (0.00%) 
Vulvovaginal Mycotic Infection † 1  0/132 (0.00%)  1/134 (0.75%) 
Injury, poisoning and procedural complications     
Burns First Degree † 1  1/132 (0.76%)  0/134 (0.00%) 
Clavicle Fracture † 1  0/132 (0.00%)  1/134 (0.75%) 
Contusion † 1  0/132 (0.00%)  2/134 (1.49%) 
Foot Fracture † 1  0/132 (0.00%)  1/134 (0.75%) 
Hand Fracture † 1  1/132 (0.76%)  0/134 (0.00%) 
Joint Dislocation † 1  0/132 (0.00%)  1/134 (0.75%) 
Muscle Strain † 1  1/132 (0.76%)  1/134 (0.75%) 
Nail Injury † 1  1/132 (0.76%)  0/134 (0.00%) 
Procedural Pain † 1  1/132 (0.76%)  0/134 (0.00%) 
Road Traffic Accident † 1  1/132 (0.76%)  0/134 (0.00%) 
Skin Laceration † 1  0/132 (0.00%)  1/134 (0.75%) 
Tooth Fracture † 1  1/132 (0.76%)  0/134 (0.00%) 
Wound † 1  0/132 (0.00%)  1/134 (0.75%) 
Investigations     
Alanine Aminotransferase Increased † 1  1/132 (0.76%)  1/134 (0.75%) 
Aspartate Aminotransferase Increased † 1  0/132 (0.00%)  1/134 (0.75%) 
Blood Creatine Phosphokinase Increased † 1  3/132 (2.27%)  2/134 (1.49%) 
Blood Pressure Increased † 1  1/132 (0.76%)  2/134 (1.49%) 
Blood Prolactin Increased † 1  1/132 (0.76%)  0/134 (0.00%) 
Blood Triglycerides Increased † 1  1/132 (0.76%)  0/134 (0.00%) 
Body Temperature Increased † 1  1/132 (0.76%)  0/134 (0.00%) 
Electrocardiogram T Wave Inversion † 1  0/132 (0.00%)  1/134 (0.75%) 
Heart Rate Increased † 1  0/132 (0.00%)  1/134 (0.75%) 
Hepatic Enzyme Increased † 1  0/132 (0.00%)  1/134 (0.75%) 
Liver Function Test Increased † 1  1/132 (0.76%)  0/134 (0.00%) 
Weight Decreased † 1  2/132 (1.52%)  3/134 (2.24%) 
Weight Increased † 1  30/132 (22.73%)  28/134 (20.90%) 
Metabolism and nutrition disorders     
Decreased Appetite † 1  2/132 (1.52%)  1/134 (0.75%) 
Diabetes Mellitus † 1  1/132 (0.76%)  0/134 (0.00%) 
Hypercalcaemia † 1  1/132 (0.76%)  0/134 (0.00%) 
Hyperglycaemia † 1  1/132 (0.76%)  0/134 (0.00%) 
Hyperuricaemia † 1  1/132 (0.76%)  0/134 (0.00%) 
Increased Appetite † 1  1/132 (0.76%)  2/134 (1.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  3/132 (2.27%)  1/134 (0.75%) 
Arthritis † 1  0/132 (0.00%)  1/134 (0.75%) 
Back Pain † 1  5/132 (3.79%)  4/134 (2.99%) 
Fasciitis † 1  1/132 (0.76%)  0/134 (0.00%) 
Fibromyalgia † 1  1/132 (0.76%)  0/134 (0.00%) 
Groin Pain † 1  0/132 (0.00%)  1/134 (0.75%) 
Joint Stiffness † 1  2/132 (1.52%)  0/134 (0.00%) 
Joint Swelling † 1  1/132 (0.76%)  0/134 (0.00%) 
Muscle Spasms † 1  3/132 (2.27%)  0/134 (0.00%) 
Muscle Twitching † 1  2/132 (1.52%)  0/134 (0.00%) 
Musculoskeletal Pain † 1  3/132 (2.27%)  0/134 (0.00%) 
Musculoskeletal Stiffness † 1  2/132 (1.52%)  0/134 (0.00%) 
Myalgia † 1  1/132 (0.76%)  1/134 (0.75%) 
Neck Pain † 1  1/132 (0.76%)  1/134 (0.75%) 
Pain in Extremity † 1  1/132 (0.76%)  1/134 (0.75%) 
Trismus † 1  1/132 (0.76%)  0/134 (0.00%) 
Nervous system disorders     
Akathisia † 1  13/132 (9.85%)  12/134 (8.96%) 
Bradykinesia † 1  1/132 (0.76%)  0/134 (0.00%) 
Disturbance In Attention † 1  1/132 (0.76%)  0/134 (0.00%) 
Dizziness † 1  2/132 (1.52%)  1/134 (0.75%) 
Dyskinesia † 1  4/132 (3.03%)  2/134 (1.49%) 
Encephalopathy † 1  0/132 (0.00%)  1/134 (0.75%) 
Extrapyramidal Disorder † 1  2/132 (1.52%)  1/134 (0.75%) 
Head Titubation † 1  0/132 (0.00%)  1/134 (0.75%) 
Headache † 1  10/132 (7.58%)  5/134 (3.73%) 
Hypoaesthesia † 1  1/132 (0.76%)  0/134 (0.00%) 
Intention Tremor † 1  1/132 (0.76%)  0/134 (0.00%) 
Loss of Consciousness † 1  0/132 (0.00%)  1/134 (0.75%) 
Oromandibular Dystonia † 1  2/132 (1.52%)  0/134 (0.00%) 
Paraesthesia † 1  0/132 (0.00%)  1/134 (0.75%) 
Parkinsonism † 1  1/132 (0.76%)  0/134 (0.00%) 
Sciatica † 1  1/132 (0.76%)  0/134 (0.00%) 
Sedation † 1  1/132 (0.76%)  0/134 (0.00%) 
Somnolence † 1  6/132 (4.55%)  4/134 (2.99%) 
Tension Headache † 1  1/132 (0.76%)  0/134 (0.00%) 
Tremor † 1  1/132 (0.76%)  4/134 (2.99%) 
Psychiatric disorders     
Agitation † 1  2/132 (1.52%)  0/134 (0.00%) 
Anxiety † 1  11/132 (8.33%)  10/134 (7.46%) 
Bipolar Disorder † 1  2/132 (1.52%)  0/134 (0.00%) 
Bruxism † 1  1/132 (0.76%)  0/134 (0.00%) 
Depressed Mood † 1  1/132 (0.76%)  0/134 (0.00%) 
Depression † 1  1/132 (0.76%)  1/134 (0.75%) 
Depressive Symptom † 1  2/132 (1.52%)  1/134 (0.75%) 
Insomnia † 1  10/132 (7.58%)  11/134 (8.21%) 
Libido Decreased † 1  0/132 (0.00%)  1/134 (0.75%) 
Psychotic Disorder † 1  1/132 (0.76%)  0/134 (0.00%) 
Psychotic Symptom † 1  0/132 (0.00%)  1/134 (0.75%) 
Restlessness † 1  3/132 (2.27%)  0/134 (0.00%) 
Schizophrenia † 1  5/132 (3.79%)  1/134 (0.75%) 
Suicidal Ideation † 1  1/132 (0.76%)  0/134 (0.00%) 
Renal and urinary disorders     
Polyuria † 1  1/132 (0.76%)  1/134 (0.75%) 
Reproductive system and breast disorders     
Erectile Dysfunction † 1  2/132 (1.52%)  2/134 (1.49%) 
Vulvovaginal Pruritus † 1  0/132 (0.00%)  1/134 (0.75%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/132 (0.76%)  0/134 (0.00%) 
Chronic Obstructive Pulmonary Disease † 1  1/132 (0.76%)  0/134 (0.00%) 
Cough † 1  2/132 (1.52%)  1/134 (0.75%) 
Hiccups † 1  1/132 (0.76%)  0/134 (0.00%) 
Nasal Congestion † 1  1/132 (0.76%)  0/134 (0.00%) 
Oropharyngeal Pain † 1  0/132 (0.00%)  2/134 (1.49%) 
Skin and subcutaneous tissue disorders     
Dermatitis Allergic † 1  1/132 (0.76%)  0/134 (0.00%) 
Dermatitis Contact † 1  0/132 (0.00%)  2/134 (1.49%) 
Erythema † 1  0/132 (0.00%)  1/134 (0.75%) 
Pruritis † 1  0/132 (0.00%)  1/134 (0.75%) 
Rash † 1  1/132 (0.76%)  0/134 (0.00%) 
Skin Fissures † 1  0/132 (0.00%)  1/134 (0.75%) 
Vascular disorders     
Hypertension † 1  2/132 (1.52%)  6/134 (4.48%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 1-609-524-6788
EMail: clinicaltransparency@otsuka-us.com
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT04030143    
Other Study ID Numbers: 031-201-00181
First Submitted: July 19, 2019
First Posted: July 23, 2019
Results First Submitted: September 22, 2023
Results First Posted: November 18, 2023
Last Update Posted: November 18, 2023