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History of Changes for Study: NCT00360399
Identifying Factors That Predict Antidepressant Treatment Response
Latest version (submitted July 27, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 2, 2006 None (earliest Version on record)
2 August 22, 2006 Study Description and Study Status
3 February 20, 2007 Recruitment Status, Study Status and Contacts/Locations
4 March 13, 2007 Contacts/Locations and Study Status
5 June 18, 2007 Contacts/Locations, Study Status and Study Design
6 February 13, 2008 Arms and Interventions, Outcome Measures, Study Status, Study Design, Oversight and Sponsor/Collaborators
7 September 25, 2008 Contacts/Locations and Study Status
8 October 16, 2008 Recruitment Status, Contacts/Locations and Study Status
9 March 9, 2009 Contacts/Locations, Outcome Measures, Study Description, Study Status, Eligibility, Study Design and Sponsor/Collaborators
10 March 27, 2009 Recruitment Status, Contacts/Locations and Study Status
11 December 14, 2011 Contacts/Locations, Sponsor/Collaborators, Study Status and References
12 April 20, 2012 Study Status and Study Design
13 October 23, 2012 Study Status, References and Eligibility
14 March 8, 2013 Sponsor/Collaborators, Study Identification and Study Status
15 April 9, 2013 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
16 November 11, 2013 Study Status and Study Identification
17 September 15, 2014 Study Status
18 July 16, 2015 Recruitment Status, Study Status and Study Design
19 June 16, 2016 Outcome Measures, Study Status and Results
20 July 27, 2016 Participant Flow, Study Status, Outcome Measures
Comparison Format:
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Study NCT00360399
Submitted Date:  June 16, 2016 (v19)
Open or close this module Study Identification
Unique Protocol ID: IRB00024975
Brief Title: Identifying Factors That Predict Antidepressant Treatment Response
Official Title: Predictors of Antidepressant Treatment Response: The Emory CIDAR
Secondary IDs: P50MH077083 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: June 2016
Overall Status: Completed
Study Start: August 2006
Primary Completion: April 2015 [Actual]
Study Completion: April 2015 [Actual]
First Submitted: August 2, 2006
First Submitted that
Met QC Criteria:		 August 2, 2006
First Posted: August 4, 2006 [Estimate]
Results First Submitted: June 16, 2016
Results First Submitted that
Met QC Criteria:		 June 16, 2016
Results First Posted: July 28, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 16, 2016
Last Update Posted: July 28, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Emory University
Responsible Party: Principal Investigator
Investigator: Helen Mayberg
Official Title: Professor
Affiliation: Emory University
Collaborators: National Institute of Mental Health (NIMH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.
Detailed Description:

Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Antidepressant medications and psychotherapy are among the effective treatments for MDD. Individuals often respond to one type of treatment, but not another. Currently, however, doctors have no way of pre-determining which individuals will most benefit from which treatments. In the absence of practical predictors of MDD treatment response, the potential efficacy of existing MDD treatments is limited. This study will identify factors that may predict MDD treatment response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in people with MDD.

Participants in this 14-week, double-blind study will be randomly assigned to receive duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2 weeks of screening, participants will complete questionnaires, clinician evaluations, an electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion of screening, patients will start the treatment to which they were randomized. Duloxetine and escitalopram are two medications that are approved by the Food and Drug Administration for the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also used to treat depression. All participants assigned to take duloxetine or escitalopram will be seen by a study physician weekly for 6 weeks, and then every other week for the remainder of the study. Participants assigned to cognitive behavioral therapy will attend therapy sessions twice a week for the first 4 weeks, and then once a week for the remainder of the study. The following assessments will be performed for all participants at each visit: vital sign and weight measurements; clinician assessments; and self-report questionnaires. Additionally, blood samples will be taken at three visits through the trial and functional magnetic resonance imaging (fMRI) scans will be performed at selected times.

A companion study to the main CIDAR study offers participants further treatment. Participants who achieve remission after the initial 12 weeks of treatment will have the option to enroll in a 21-month follow-up study of maintenance treatment, with visits every three months to monitor for sustained response and relapse. Participants who do not remit will have the option to enroll in another 12-week treatment course, receiving a combination of CBT and medication. Participants who achieve response after this combination treatment will be eligible to receive maintenance combination treatment for up to an additional 18 months, monitored for sustained response and relapse. Participants who do not wish to enroll or continue in the companion study will be provided with a referral for treatment with another mental health provider.
Open or close this module Conditions
Conditions: Depression
Keywords: Escitalopram
Duloxetine
Cognitive Behavioral Therapy
PET
fMRI
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 344 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Escitalopram
Participants will receive treatment with escitalopram for 12 weeks
 Drug: Escitalopram
Escitalopram 10 to 20 mg per day for 12 weeks
Other Names:
  • Lexapro
Active Comparator: Duloxetine
Participants will receive treatment with duloxetine for 12 weeks
 Drug: Duloxetine
Duloxetine 30 to 60 mg per day for 12 weeks
Other Names:
  • Cymbalta
Active Comparator: CBT
Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks
 Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 16 one-hour sessions provided over 12 weeks.
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Remission From Major Depressive Episode in Intent to Treat Sample
[ Time Frame: Up to 12 Weeks ]

The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.
2. Remission From Major Depressive Episode Among Participants Who Completed the Intervention
[ Time Frame: Measured at Weeks 10 and 12 ]

The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.
Secondary Outcome Measures:
1. Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
[ Time Frame: Up to 12 Weeks ]

Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:

  1. Non-response: <30% reduction from baseline
  2. Partial Response: 30-49% reduction from baseline
  3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
  4. Remission: HDRS score ≤7
2. Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
[ Time Frame: Measured at Weeks 10 and 12 ]

Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:

  1. Non-response: <30% reduction from baseline
  2. Partial Response: 30-49% reduction from baseline
  3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
  4. Remission: HDRS score ≤7
3. Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
[ Time Frame: Measured at 6, 12, 15, 18, 21, and 24 months ]

The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.
4. Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy
[ Time Frame: Measured after 12 weeks of combined treatment ]

The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
  • Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be criteria for exclusion)
  • Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
  • Agrees to use an effective form of contraception and/or double barrier method

Exclusion Criteria:

  • Previously treated for major depression with either medication or psychotherapy
  • Current psychosis, dementia, eating disorder, or dissociative disorder
  • History of bipolar disorder (I and II) or schizophrenia
  • Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening
  • Requires neuroleptic or mood stabilizer therapy in addition to depression treatment
  • Presence of any acute or chronic medical disorder that could affect successful completion of the trial
  • Medical contraindications that would preclude treatment with escitalopram or duloxetine
  • Presence of practical issues that would likely prevent completion of the study (e.g., planned geographical relocation)
  • Pregnant or breastfeeding
  • Medical conditions that could prevent the safe use of MRI (e.g., pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants; steel worker)
  • Medical conditions that could prevent the safe completion of a dexamethasone-corticotropin releasing factor (Dex-CRF) test (e.g., uncontrolled hypertension, significant abnormalities in EKG, anemia, known allergies against drugs)
Open or close this module Contacts/Locations
Study Officials: Helen S. Mayberg, MD
Principal Investigator
Emory University
W. Edward Craighead, PhD
Principal Investigator
Emory University
Locations: United States, Georgia
Emory University Mood and Anxiety Disorders Program
Atlanta, Georgia, United States, 30306
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Dunlop BW, Binder EB, Cubells JF, Goodman MM, Kelley ME, Kinkead B, Kutner M, Nemeroff CB, Newport DJ, Owens MJ, Pace TW, Ritchie JC, Rivera VA, Westen D, Craighead WE, Mayberg HS. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial. Trials. 2012 Jul 9;13:106. doi: 10.1186/1745-6215-13-106. PubMed 22776534
Links: Description: Related Info
Available IPD/Information:
Study Results
Open or close this module Participant Flow
Recruitment Details Participants were recruited through the Emory University Mood and Anxiety Disorders Program. Men and women, aged 18-65, meeting DSM-IV criteria for a current major depressive disorder, and who had not received prior treatment for a mood disorder were eligible. 515 consented to participate in the trial and 344 were randomized to a treatment arm.
Pre-assignment Details

A total of 344 participants were randomized as follows:

114 randomized to the Escitalopram arm 115 randomized to the Duloxetine arm 115 randomized to the Cognitive behavioral therapy (CBT) arm

28 participants did not return for a post-randomization assessment, resulting in 316 participants with data to analyze.

 
Arm/Group Title Escitalopram Duloxetine Cognitive Behavioral Therapy (CBT)
Arm/Group Description Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Period Title: Overall Study
Started 105 106 105
Completed 86 79 69
Not Completed 19 27 36
Open or close this module Baseline Characteristics
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)Total
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeksTotal of all reporting groups
Overall Number of Baseline Participants 114 115 115 344
Baseline Analysis Population Description
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
114
100%
115
100%
115
100%
344
100%
>=65 years
0
0%
0
0%
0
0%
0
0%
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed114 Participants115 Participants115 Participants344 Participants
41.6(12.1)38.3(11.4)40.0(11.3)40.0(11.7)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
Female
64
56.14%
68
59.13%
64
55.65%
196
56.98%
Male
50
43.86%
47
40.87%
51
44.35%
148
43.02%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
Hispanic or Latino
36
31.58%
34
29.57%
32
27.83%
102
29.65%
Not Hispanic or Latino
78
68.42%
81
70.43%
83
72.17%
242
70.35%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) [1]
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
28
24.56%
23
20%
13
11.3%
64
18.6%
White
47
41.23%
56
48.7%
61
53.04%
164
47.67%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
39
34.21%
36
31.3%
41
35.65%
116
33.72%
 
[1]Measure Description: The race of participants was categorized as "Caucasian", "Black", and "Other".
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
United States
114115115344
Current Anxiety Disorder
Measure Type: Number
Unit of measure: participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
Yes
676771205
No
474844139
Previous Episode(s) of Depression [1]
Measure Type: Number
Unit of measure: participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
One
595167177
Two
20261763
Three or more
33382899
None
2035
 
[1]Measure Description: The number of participants who have had 1, 2, or 3 or more prior episodes of depression
Chronic Episode of Depression (2 or More Years) [1]
Measure Type: Number
Unit of measure: participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
Yes
313738106
No
837877238
 
[1]Measure Description: The number of participants who are experiencing a chronic episode of depression (2 or more years in duration).
History of Suicide Attempt [1]
Measure Type: Number
Unit of measure: participants
Number Analyzed114 Participants115 Participants115 Participants344 Participants
Yes
413825
No
110102107319
 
[1]Measure Description: The number of participants who have a prior history of suicide attempt.
Open or close this module Outcome Measures
1. Primary Outcome:
Title Remission From Major Depressive Episode in Intent to Treat Sample
Description The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.
Time Frame Up to 12 Weeks
Outcome Measure Data
Analysis Population Description
This population consists of all participants who were randomized and returned for at least one study visit. This population was used for the intent to treat analyses and not all of these individuals completed the study.
 
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Overall Number of Participants Analyzed105 106 105
Measure Type: Number
Unit of Measure: percentage of participants
46.7 54.7 41.9
2. Primary Outcome:
Title Remission From Major Depressive Episode Among Participants Who Completed the Intervention
Description The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.
Time Frame Measured at Weeks 10 and 12
Outcome Measure Data
Analysis Population Description
This population includes participants who completed the trial, per study protocol.
 
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Overall Number of Participants Analyzed86 79 69
Measure Type: Number
Unit of Measure: percentage of participants
44.2 51.9 43.5
3. Secondary Outcome:
Title Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
Description

Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:

  1. Non-response: <30% reduction from baseline
  2. Partial Response: 30-49% reduction from baseline
  3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
  4. Remission: HDRS score ≤7
Time Frame Up to 12 Weeks
Outcome Measure Data
Analysis Population Description
The population is defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment.
 
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Overall Number of Participants Analyzed105 106 105
Measure Type: Number
Unit of Measure: participants
Non-Response
26
24.8%
21
19.8%
32
30.5%
Partial Response
12
11.4%
16
15.1%
19
18.1%
Response without remission
18
17.1%
11
10.4%
10
9.5%
Remission
49
46.7%
58
54.7%
44
41.9%
4. Secondary Outcome:
Title Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
Description

Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:

  1. Non-response: <30% reduction from baseline
  2. Partial Response: 30-49% reduction from baseline
  3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
  4. Remission: HDRS score ≤7
Time Frame Measured at Weeks 10 and 12
Outcome Measure Data
Analysis Population Description
This population includes participants who completed the trial, per study protocol.
 
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Overall Number of Participants Analyzed86 79 69
Measure Type: Number
Unit of Measure: participants
Non-Response
15
17.4%
10
12.7%
15
21.7%
Partial Response
10
11.6%
12
15.2%
13
18.8%
Response without remission
23
26.7%
16
20.3%
11
15.9%
Remission
38
44.2%
41
51.9%
30
43.5%
5. Secondary Outcome:
Title Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
Description The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.
Time Frame Measured at 6, 12, 15, 18, 21, and 24 months
Outcome Measure Data
Analysis Population Description
This population is comprised of participants who completed 12 weeks of treatment, achieved remission, and participated in a follow-up phase that lasted for up to 21 months or until recurrence occurred.
 
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Overall Number of Participants Analyzed34 38 24
Measure Type: Number
Unit of Measure: participants
6 Months
0
0%
0
0%
1
4.2%
9 Months
1
2.9%
2
5.3%
1
4.2%
12 Months
1
2.9%
2
5.3%
3
12.5%
15 Months
1
2.9%
4
10.5%
5
20.8%
18 Months
2
5.9%
4
10.5%
5
20.8%
21 Months
3
8.8%
5
13.2%
5
20.8%
24 Months
3
8.8%
5
13.2%
5
20.8%
6. Secondary Outcome:
Title Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy
Description The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks
Time Frame Measured after 12 weeks of combined treatment
Outcome Measure Data
Analysis Population Description
Participants who did not achieve remission during monotherapy were offered 12 weeks of combination therapy. This sample consists of those participants who consented for the combination therapy part of the trial and who completed the 12 weeks of treatment.
 
Arm/Group TitleEscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
Arm/Group DescriptionParticipants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per dayParticipants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per dayParticipants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Overall Number of Participants Analyzed41 25 31
Measure Type: Number
Unit of Measure: participants
22
53.7%
10
40%
18
58.1%
Open or close this module Adverse Events
 
Time Frame Adverse events will be collected during the entire time a participant remains in the trial (up to 24 weeks)
Adverse Event Reporting Description [Not specified]
 
Arm/Group Title Escitalopram Duloxetine Cognitive Behavioral Therapy (CBT)
Arm/Group Description Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
All-Cause Mortality
  EscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total / / /
Serious Adverse Events
  EscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 6 / 114 (5.26%)3 / 115 (2.61%)1 / 115 (0.87%)
General disorders
Motor Vehicle Accident 2 / 114 (1.75%)21 / 115 (0.87%)10 / 115 (0%)0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer 1 / 114 (0.88%)10 / 115 (0%)00 / 115 (0%)0
Psychiatric disorders
AttemptedSuicide by Overdose 0 / 114 (0%)02 / 115 (1.74%)20 / 115 (0%)0
Renal and urinary disorders
Urinary retention 1 / 114 (0.88%)10 / 115 (0%)00 / 115 (0%)0
Respiratory, thoracic and mediastinal disorders
Hospitalization for asthma attack 0 / 114 (0%)00 / 115 (0%)01 / 115 (0.87%)1
Skin and subcutaneous tissue disorders
Laceration 1 / 114 (0.88%)10 / 115 (0%)00 / 115 (0%)0
Vascular disorders
Deep vein thrombosis 1 / 114 (0.88%)10 / 115 (0%)00 / 115 (0%)0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  EscitalopramDuloxetineCognitive Behavioral Therapy (CBT)
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 100 / 114 (87.72%)108 / 115 (93.91%)70 / 115 (60.87%)
Cardiac disorders
Palpitations 2 / 114 (1.75%)6 / 115 (5.22%)0 / 115 (0%)
Eye disorders
Blurred Vision 6 / 114 (5.26%)4 / 115 (3.48%)2 / 115 (1.74%)
Gastrointestinal disorders
Abdominal Pain 7 / 114 (6.14%)13 / 115 (11.3%)7 / 115 (6.09%)
Constipation 9 / 114 (7.89%)13 / 115 (11.3%)2 / 115 (1.74%)
Diarrhea 23 / 114 (20.18%)22 / 115 (19.13%)11 / 115 (9.57%)
Dyspepsia 9 / 114 (7.89%)10 / 115 (8.7%)6 / 115 (5.22%)
Flatulence 6 / 114 (5.26%)5 / 115 (4.35%)3 / 115 (2.61%)
Nausea 29 / 114 (25.44%)37 / 115 (32.17%)8 / 115 (6.96%)
General disorders
Bruxism 8 / 114 (7.02%)6 / 115 (5.22%)1 / 115 (0.87%)
Dizziness 16 / 114 (14.04%)21 / 115 (18.26%)4 / 115 (3.48%)
Dry Mouth 18 / 114 (15.79%)28 / 115 (24.35%)2 / 115 (1.74%)
Fatigue 22 / 114 (19.3%)27 / 115 (23.48%)2 / 115 (1.74%)
Feeling Jittery 6 / 114 (5.26%)7 / 115 (6.09%)0 / 115 (0%)
Headache 36 / 114 (31.58%)38 / 115 (33.04%)19 / 115 (16.52%)
Insomnia 20 / 114 (17.54%)26 / 115 (22.61%)3 / 115 (2.61%)
Sedation 15 / 114 (13.16%)18 / 115 (15.65%)4 / 115 (3.48%)
Somnolence 8 / 114 (7.02%)5 / 115 (4.35%)1 / 115 (0.87%)
Yawning 7 / 114 (6.14%)10 / 115 (8.7%)2 / 115 (1.74%)
Metabolism and nutrition disorders
Decreased Appetite 7 / 114 (6.14%)9 / 115 (7.83%)1 / 115 (0.87%)
Increased Appetite 7 / 114 (6.14%)1 / 115 (0.87%)1 / 115 (0.87%)
Musculoskeletal and connective tissue disorders
Back Pain 4 / 114 (3.51%)7 / 115 (6.09%)3 / 115 (2.61%)
Psychiatric disorders
Anxiety 9 / 114 (7.89%)10 / 115 (8.7%)3 / 115 (2.61%)
Emotional Poverty 9 / 114 (7.89%)1 / 115 (0.87%)0 / 115 (0%)
Reproductive system and breast disorders
Abnormal Orgasm 3 / 114 (2.63%)9 / 115 (7.83%)1 / 115 (0.87%)
Anorgasmia 12 / 114 (10.53%)7 / 115 (6.09%)2 / 115 (1.74%)
Decreased Libido 12 / 114 (10.53%)11 / 115 (9.57%)2 / 115 (1.74%)
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection 14 / 114 (12.28%)31 / 115 (26.96%)27 / 115 (23.48%)
Skin and subcutaneous tissue disorders
Hyperhidrosis 4 / 114 (3.51%)9 / 115 (7.83%)0 / 115 (0%)
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Certain Agreements:
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact:
Name/Official Title:
 Helen Mayberg
Organization:
 Emory University
Phone:
 404-727-6740
Email:
 hmayber@emory.edu
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