A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

• ClinicalTrials.gov Identifier: NCT03672175
• Recruitment Status: Completed
• First Posted: September 14, 2018
• Results First Posted: November 10, 2022
• Last Update Posted: November 29, 2023
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

Study Description

Brief Summary:

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: SAGE-217; Drug: Placebo	Phase 3

Detailed Description:

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 581 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
• Actual Study Start Date: November 19, 2018
• Actual Primary Completion Date: September 24, 2019
• Actual Study Completion Date: March 17, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: SAGE-217 Matched Placebo; Participants self-administered SAGE-217 matched placebo capsules, orally, once daily in the evening with food for 14 days.	Drug: Placebo; SAGE-217 matched placebo hard gelatin capsules.
Experimental: SAGE-217 20 mg; Participants self-administered SAGE-217 20 milligrams (mg) capsules, orally, once daily in the evening with food for 14 days.	Drug: SAGE-217; SAGE-217 hard gelatin capsules.
Experimental: SAGE-217 30 mg; Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.	Drug: SAGE-217; SAGE-217 hard gelatin capsules.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in the 17-item HAM-D Total Score at Day 15 [ Time Frame: Baseline (BL), Day 15 ]
   The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. A negative change from baseline indicates less depression.

Secondary Outcome Measures :

1. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15 [ Time Frame: Baseline, Day 15 ]
   The CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness relative to the clinician's past experience with participants who had the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill. A higher score indicates extreme illness/more severity. A negative change from baseline indicates less severe illness.
2. Change From Baseline in the 17-item HAM-D Total Score [ Time Frame: Baseline, Days 3, 8, 42, and 182 ]
   The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. A negative change from baseline indicates less depression.
3. Number of Participants Achieving HAM-D Response [ Time Frame: Days 15, 42, and 182 ]
   HAM-D response is defined as a ≥50% reduction in HAM-D score from baseline. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression.
4. Number of Participants Achieving HAM-D Remission [ Time Frame: Days 15, 42, and 182 ]
   HAM-D remission is defined as HAM-D total score ≤7. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression.
5. Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at Day 15 [ Time Frame: Day 15 ]
   CGI-I response is defined as a CGI-I score of very much improved or much improved. The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The Investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
6. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 15 [ Time Frame: Baseline, Day 15 ]
   The 14-item HAM-A is used to rate the severity of symptoms of anxiety. Each of the 14 items is defined by a series of symptoms and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe) to each item. Total HAM-A score is calculated as the sum of the 14 individual item scores with a total score range of 0 to 56, where the score of <17 indicates mild severity, 18 to 24 indicates mild to moderate severity, and 25 to 30 indicates moderate to severe severity. A negative change from baseline indicates less severe symptoms.
7. Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 [ Time Frame: Baseline, Day 15 ]
   The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). Total MADRS score, calculated as the sum of the 10 individual items, ranges from 0 to 60 with a higher score indicating more depression. A negative change from baseline indicates less severe symptoms.
8. Change From Baseline in HAM-D Core Subscale Score [ Time Frame: Baseline, Days 15, and 42 ]
   The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The core subscale score is the sum of the following symptom scores, scored in a range of 0 to 4: Depressed mood, feelings of guilt, suicide, work and activities, and retardation. Total HAM-D core subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression. A negative change from baseline indicates less depression.
9. Change From Baseline in HAM-D Anxiety Subscale Score [ Time Frame: Baseline, Days 15, and 42 ]
   The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The anxiety subscale score is the sum of the following symptom scores: Anxiety (psychic and somatic) [scored in a range of 0 to 4], somatic symptoms (gastrointestinal and general) [scored in a range of 0 to 2], hypochondriasis [scored in a range of 0 to 4], and loss of weight [scored in a range of 0 to 2]. Total HAM-D anxiety subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression/anxiety. A negative change from baseline indicates less depression.
10. Change From Baseline in HAM-D Bech-6 Subscale Score [ Time Frame: Baseline, Days 15, and 42 ]
    The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The Bech-6 subscale score is the sum of the following symptom scores, scored in a range of 0 to 4: Depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general. Total HAM-D Bech-6 subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression. A negative change from baseline indicates less depression.
11. Change From Baseline in HAM-D Maier Subscale Score [ Time Frame: Baseline, Days 15, and 42 ]
    The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The Maier subscale score is the sum of the following symptom scores, scored in a range of 0 to 4: Depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic. Total HAM-D Maier subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression. A negative change from baseline indicates less depression.
12. Change From Baseline in HAM-D Individual Item Scores [ Time Frame: Baseline, Days 15, and 42 ]
    The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight (according to participant), and insight. The following symptoms are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. For each symptom, higher scores indicate more severe depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
13. Change From Baseline in Insomnia Severity Index (ISI) Total Score [ Time Frame: Baseline, Days 15, and 42 ]
    The ISI is a validated questionnaire designed to assess the nature, severity, and impact of insomnia. The ISI uses a 5-point Likert scale to measure various aspects of insomnia severity (0=none, 1=mild, 2=moderate; 3=severe; 4=very severe), satisfaction with current sleep pattern (0=very satisfied, 1=satisfied, 2=moderately satisfied, 3=dissatisfied, 4=very dissatisfied), and various aspects of the impact of insomnia on daily functioning (0=not at all, 1=a little, 2=somewhat, 3=much, 4=very much). The ISI total score is calculated as the sum of the 7 individual item scores and the possible total score range is from 0 to 28, categorized as follows: 0 to 7=no clinically significant insomnia, 8 to 14=subthreshold insomnia, 15 to 21=clinical insomnia (moderate severity), and 22 to 28=clinical insomnia (severe). Higher scores indicate more severity. A negative change from baseline indicates less severe insomnia.
14. Change From Baseline in Core Consensus Sleep Diary Parameters: Sleep Onset Latency (sSL), Wake After Sleep Onset (sWASO), and Total Sleep Time (sTST) [ Time Frame: Baseline, Days 15, and 28 ]
    The Core Consensus Sleep Diary collected subjective responses to a series of questions related to participant's daily sleep pattern (i.e., time to bed, time to fall asleep, time to final awakening, and a question related to quality of sleep) to derive sleep parameters, including sSL, sTST, and sWASO. The take-home participant sleep diary assessment was administered using an eDiary solution. The eDiary was captured using either a provisioned smartphone device or a bring-your-own-device solution, depending on the participant's preference. sTST is a derived parameter calculated as: Time of final awakening - (time when tried to sleep + time taken to fall asleep)-time of being awake after sleep onset. Negative change from baseline in sSL and sWASO indicates improvement. Positive change from baseline in sTST indicates improvement.
15. Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Awakenings (sNAW) [ Time Frame: Baseline, Days 15, and 28 ]
    The Core Consensus Sleep Diary was used to collect subjective sleep parameter of sNAW. sNAW was calculated from the onset of persistent sleep until lights on. An awakening is defined as at least 2 consecutive epochs of wake. Individual awakenings were separated by at least 1 epoch of Stage N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles), N3 (slow wave or deep sleep) or rapid eye movement (REM) sleep. Lower ratings indicate better sleep quality and more refreshing/restorative quality of sleep.
16. Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Participants With Subjective Sleep Quality (sSQ) Response [ Time Frame: Baseline, Days 15, and 28 ]
    The Core Consensus Sleep Diary collected subjective sleep parameters, including sleep quality (sSQ). The take-home participant sleep diary assessment was administered using an eDiary solution. The eDiary was captured using either a provisioned smartphone device or a bring-your-own-device solution, depending on the participant's preference. sSQ is rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality. sSQ response is defined as having a sSQ score of very good or good.
17. Change From Baseline in the 36-item Short Form Survey Version 2 (SF-36v2) Physical and Mental Component Summary Scores [ Time Frame: Baseline, Days 15, and 42 ]
    Participant's health was assessed using Patient-reported outcome (PRO) health related quality of life (HRQOL), SF-36v2 which is a 36-item measure of health status. It covers eight health dimensions including four physical health status domains (physical functioning, role participation with physical health problems, bodily pain, and general health) and four mental health status domains (vitality, social functioning, role participation with emotional health problems, and mental health). Two summary scores, physical component summary (PCS), and mental component summary (MCS) were produced by taking a weighted linear combination of the eight individual domains. The score range for PCS and MCS is 0 to 100 (100=highest level of functioning). Higher scores indicate a better state of health. A negative change from baseline indicates deteriorating health.
18. Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Total Score [ Time Frame: Baseline, Days 15, and 42 ]
    The PHQ-9 is a participant-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants' responses to each of the 9 questions, as follows: 0=not at all; 1=several days; 2=more than half the days; and 3=nearly every day. The PHQ-9 total score was calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 1 to 4=minimal depression, 5 to 9=mild depression, 10 to 14=moderate depression, 15 to 19=moderately severe depression; and 20 to 27=severe depression. Higher scores indicate more severe depression. A negative change from baseline indicates reduced depression.
19. Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods [ Time Frame: Treatment period: Up to Day 14; FU period: Day 15 to 42 ]
    An adverse event (AE) is any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. A serious TEAE is defined as a TEAE that at any dose results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or results in a congenital abnormality or birth defect.
20. Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Extended FU Period [ Time Frame: Extended FU Period: Day 43 to 182 ]
    An adverse event (AE) is any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. A serious TEAE is defined as a TEAE that at any dose results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or results in a congenital abnormality or birth defect.
21. Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods [ Time Frame: Treatment period: Up to Day 14; FU period: Day 15 to 42 ]
    Laboratory parameters include serum chemistry- Alanine aminotransferase: >3x upper limit of normal (ULN); Alanine aminotransferase or aspartate aminotransferase: >3x ULN; Bilirubin: >1.5x ULN, >2x ULN; Calcium: <2.0 millimoles per liter (mmol/L); Gamma Glutamyl Transferase [units per liter (U/L)]: >3xULN; Potassium: >5.4 mmol/L; Sodium: >150 mmol/L; Hematology- Hematocrit : Male <0.385 liter/liter (L/L) and Female <0.345 L/L and Male >0.55 L/L and Female >0.49 L/L; Hemoglobin: Male <115 grams/liter (g/L) and Female <100 g/L; Neutrophils: <1.5 10^9/L.
22. Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Extended FU Period [ Time Frame: Extended FU Period: Day 43 to 182 ]
    Laboratory parameters include serum chemistry- Alanine aminotransferase: >3x upper limit of normal (ULN); Alanine aminotransferase or aspartate aminotransferase: >3x ULN; Bilirubin: >1.5x ULN, >2x ULN; Calcium: <2.0 millimoles per liter (mmol/L); Gamma Glutamyl Transferase [units per liter (U/L)]: >3xULN; Potassium: >5.4 mmol/L; Sodium: >150 mmol/L; Hematology- Hematocrit : Male <0.385 liter/liter (L/L) and Female <0.345 L/L and Male >0.55 L/L and Female >0.49 L/L; Hemoglobin: Male <115 grams/liter (g/L) and Female <100 g/L; Neutrophils: <1.5 10^9/L.
23. Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods [ Time Frame: Treatment period: Up to Day 14; FU period: Day 15 to 42 ]
    Vital signs include supine and standing systolic blood pressure (SBP) [millimeters of mercury (mmHg)]: <90, >180, increase and decrease from baseline of >=30; Supine and standing diastolic blood pressure (DBP) (mmHg): Increase and decrease from baseline >=20; Standing heart rate (>120 beats per minute); Orthostatic SBP (>=20); Orthostatic DBP (>=10); Orthostatic hypotension (SBP >=20 and DBP >=10, SBP >=20 or DBP >=10).
24. Number of Participants With Clinically Significant Vital Sign Abnormalities in Extended FU Period [ Time Frame: Extended FU Period: Day 43 to 182 ]
    Vital signs include supine and standing SBP [mmHg]: <90, >180, increase and decrease from baseline of >=30; Supine and standing DBP (mmHg): Increase and decrease from baseline >=20; Standing heart rate (>120 beats per minute); Orthostatic SBP (>=20); Orthostatic DBP (>=10); Orthostatic hypotension (SBP >=20 and DBP >=10, SBP >=20 or DBP >=10).
25. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods [ Time Frame: Treatment period: Up to Day 14; FU period: Day 15 to 42 ]
    Supine 12-lead ECGs were performed in triplicate and the standard intervals (heart rate, PR, QRS, QT, and corrected QT interval by Fridericia [QTcF]) as well as any rhythm abnormalities were recorded. Criteria for clinically significant ECG abnormalities included QTcF interval (msec)- females: >450 to 480, male: >450 to 470, females: >480 to 500, male: >470 to 500 or >500.
26. Number of Participants With Clinically Significant ECG Abnormalities in Extended FU Period [ Time Frame: Extended FU Period: Day 43 to 182 ]
    Supine 12-lead ECGs were performed in triplicate and the standard intervals (heart rate, PR, QRS, QT, and QTcF) as well as any rhythm abnormalities were recorded. Criteria for clinically significant ECG abnormalities included QTcF interval (msec)- females: >450 to 480, male: >450 to 470, females: >480 to 500, male: >470 to 500 or >500.
27. Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Double-blind Treatment Period at Day 42 [ Time Frame: Day 42 ]
    Suicidality was monitored during the study using the C-SSRS scale. The C-SSRS includes 'yes' or 'no' responses for 5 questions for assessment of suicidal ideation and behavior. Any suicidal behavior: When response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: When response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.
28. Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Extended FU Period at Day 182 [ Time Frame: Day 182 ]
    Suicidality was monitored during the study using the C-SSRS scale. The C-SSRS includes 'yes' or 'no' responses for 5 questions for assessment of suicidal ideation and behavior. Any suicidal behavior: When response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: When response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.
29. Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score [ Time Frame: Baseline, Days 15, 18, and 21 ]
    The PWC-20 was used to monitor for the presence of potential withdrawal symptoms following discontinuation of SAGE-217. The PWC-20 was made up of a list of 20 symptoms (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue-lethargy-lack of energy, poor coordination, restlessness-agitation, diaphoresis, tremor-tremulousness, dizziness-lightheadedness, headaches, muscle aches or stiffness, weakness, increased acuity [sound, smell, touch, pain], paresthesia, difficulty concentrating and remembering, depersonalization-derealization) that were rated on a scale of 0 (not present) to 3 (severe). The PWC-20 total score was derived as the sum of individual item scores, which ranges from 0 (not present) to 60 (severe). Higher scores indicate more severe withdrawal. A negative change from baseline indicates less severe withdrawal.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant had active psychosis.
2. Participant had attempted suicide associated with the current episode of MDD.
3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Contacts and Locations

Locations

United States, Arkansas

Sage Investigational Site

Rogers, Arkansas, United States, 72758

United States, California

Sage Investigational Site

Bellflower, California, United States, 90706

Sage Investigational Site

Garden Grove, California, United States, 92845

Sage Investigational Site

Glendale, California, United States, 91206

Sage Investigational Site

National City, California, United States, 91950

Sage Investigational Site

Oakland, California, United States, 94607

Sage Investigational Site

Oceanside, California, United States, 92054

Sage Investigational Site

Orange, California, United States, 92868

Sage Investigational Site

Pico Rivera, California, United States, 90660

Sage Investigational Site

Redlands, California, United States, 92374

Sage Investigational Site

San Diego, California, United States, 92103

Sage Investigational Site

Sherman Oaks, California, United States, 91403

Sage Investigational Site

Temecula, California, United States, 92591

United States, Florida

Sage Investigational Site

Coral Springs, Florida, United States, 33067

Sage Investigational Site

Hollywood, Florida, United States, 33024

Sage Investigational Site

Jacksonville, Florida, United States, 32256

Sage Investigational Site

Lauderhill, Florida, United States, 33319

Sage Investigational Site

Maitland, Florida, United States, 32750

Sage Investigational Site

North Miami, Florida, United States, 33161

Sage Investigational Site

Orange City, Florida, United States, 32763

Sage Investigational Site

Orlando, Florida, United States, 32801

Sage Investigational Site

Orlando, Florida, United States, 32807

United States, Georgia

Sage Investigational Site

Atlanta, Georgia, United States, 30328

Sage Investigational Site

Atlanta, Georgia, United States, 30331

Sage Investigational Site

Atlanta, Georgia, United States, 30341

Site Investigational Site

Decatur, Georgia, United States, 30030

United States, Illinois

Sage Investigational Site

Skokie, Illinois, United States, 60076

United States, Maryland

Sage Investigational Site

Pikesville, Maryland, United States, 21208

United States, Mississippi

Sage Investigational Site

Flowood, Mississippi, United States, 39110

Sage Investigational Site

Flowood, Mississippi, United States, 39232

United States, Missouri

Sage Investigational Site

O'Fallon, Missouri, United States, 63368

Sage Investigational Site

Saint Louis, Missouri, United States, 63141

United States, Nevada

Sage Investigational Site

Las Vegas, Nevada, United States, 89102

United States, New Jersey

Sage Investigational Site

Berlin, New Jersey, United States, 08009

United States, New York

Sage Investigational Site

Jamaica, New York, United States, 11432

Sage Investigational Site

Rochester, New York, United States, 14618

United States, North Carolina

Sage Investigational Site

Charlotte, North Carolina, United States, 28211

United States, Ohio

Sage Investigational Site

Cincinnati, Ohio, United States, 45215

Sage Investigational Site

Dayton, Ohio, United States, 45417

Sage Investigational Site

North Canton, Ohio, United States, 44720

United States, Oklahoma

Sage Investigational Site

Oklahoma City, Oklahoma, United States, 73106

Sage Investigational Site

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

Sage Investigational Site

Portland, Oregon, United States, 97210

Sage Investigational Site

Portland, Oregon, United States, 97214

United States, Pennsylvania

Sage Investigational Site

Allentown, Pennsylvania, United States, 18104

United States, South Carolina

Sage Investigational Site

Charleston, South Carolina, United States, 29407

United States, Tennessee

Sage Investigational Site

Memphis, Tennessee, United States, 38119

United States, Texas

Sage Investigational Site

Austin, Texas, United States, 78754

Sage Investigational Site

Bellaire, Texas, United States, 77401

Sage Investigational Site

DeSoto, Texas, United States, 75115

Sage Investigational Site

Richardson, Texas, United States, 75080

Sage Investigational Site

Wichita Falls, Texas, United States, 76309

United States, Virginia

Sage Investigational Site

Charlottesville, Virginia, United States, 22903

Sponsors and Collaborators

Biogen

  Study Documents (Full-Text)

Documents provided by Biogen:

Study Protocol  [PDF] March 25, 2019

Statistical Analysis Plan  [PDF] November 12, 2019

More Information

Additional Information:

Related Info 

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT03672175
• Other Study ID Numbers: 217-MDD-301
• First Posted: September 14, 2018
• Results First Posted: November 10, 2022
• Last Update Posted: November 29, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
• URL: https://vivli.org/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Zuranolone; Antidepressive Agents; Psychotropic Drugs