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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

SAGE-217

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
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:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

SAGE-217 Matched Placebo

SAGE-217 20 mg

SAGE-217 30 mg

Arm Description

Participants self-administered SAGE-217 matched placebo capsules, orally, once daily in the evening with food for 14 days.

Participants self-administered SAGE-217 20 milligrams (mg) capsules, orally, once daily in the evening with food for 14 days.

Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.

Outcomes

Primary Outcome Measures

Change From Baseline in the 17-item HAM-D Total Score at 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

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at 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.

Change From Baseline in the 17-item HAM-D Total Score

Number of Participants Achieving HAM-D Response

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.

Number of Participants Achieving HAM-D Remission

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.

Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at 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.

Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at 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.

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 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.

Change From Baseline in HAM-D Core Subscale Score

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.

Change From Baseline in HAM-D Anxiety Subscale Score

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.

Change From Baseline in HAM-D Bech-6 Subscale Score

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.

Change From Baseline in HAM-D Maier Subscale Score

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.

Change From Baseline in HAM-D Individual Item Scores

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.

Change From Baseline in Insomnia Severity Index (ISI) Total Score

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.

Change From Baseline in Core Consensus Sleep Diary Parameters: Sleep Onset Latency (sSL), Wake After Sleep Onset (sWASO), and Total Sleep Time (sTST)

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.

Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Awakenings (sNAW)

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.

Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Participants With Subjective Sleep Quality (sSQ) Response

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.

Change From Baseline in the 36-item Short Form Survey Version 2 (SF-36v2) Physical and Mental Component Summary Scores

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.

Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Total Score

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.

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods

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.

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Extended FU Period

Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods

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.

Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Extended FU Period

Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods

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).

Number of Participants With Clinically Significant Vital Sign Abnormalities in Extended FU Period

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).

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods

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.

Number of Participants With Clinically Significant ECG Abnormalities in Extended FU Period

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.

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

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.

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

Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score

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.

Full Information

NCT ID

NCT03672175

First Posted

September 12, 2018

Last Updated

November 22, 2022

Sponsor

Sage Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03672175

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

November 19, 2018 (Actual)

Primary Completion Date

September 24, 2019 (Actual)

Study Completion Date

March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

581 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAGE-217 Matched Placebo

Arm Type

Placebo Comparator

Arm Description

Participants self-administered SAGE-217 matched placebo capsules, orally, once daily in the evening with food for 14 days.

Arm Title

SAGE-217 20 mg

Arm Type

Experimental

Arm Description

Participants self-administered SAGE-217 20 milligrams (mg) capsules, orally, once daily in the evening with food for 14 days.

Arm Title

SAGE-217 30 mg

Arm Type

Experimental

Arm Description

Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.

Intervention Type

Drug

Intervention Name(s)

SAGE-217

Intervention Description

SAGE-217 hard gelatin capsules.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

SAGE-217 matched placebo hard gelatin capsules.

Primary Outcome Measure Information:

Title

Change From Baseline in the 17-item HAM-D Total Score at Day 15

Description

Time Frame

Baseline (BL), Day 15

Secondary Outcome Measure Information:

Title

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15

Description

Time Frame

Baseline, Day 15

Title

Change From Baseline in the 17-item HAM-D Total Score

Description

Time Frame

Baseline, Days 3, 8, 42, and 182

Title

Number of Participants Achieving HAM-D Response

Description

Time Frame

Days 15, 42, and 182

Title

Number of Participants Achieving HAM-D Remission

Description

Time Frame

Days 15, 42, and 182

Title

Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at Day 15

Description

Time Frame

Day 15

Title

Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 15

Description

Time Frame

Baseline, Day 15

Title

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15

Description

Time Frame

Baseline, Day 15

Title

Change From Baseline in HAM-D Core Subscale Score

Description

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in HAM-D Anxiety Subscale Score

Description

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.

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in HAM-D Bech-6 Subscale Score

Description

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.

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in HAM-D Maier Subscale Score

Description

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.

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in HAM-D Individual Item Scores

Description

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in Insomnia Severity Index (ISI) Total Score

Description

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in Core Consensus Sleep Diary Parameters: Sleep Onset Latency (sSL), Wake After Sleep Onset (sWASO), and Total Sleep Time (sTST)

Description

Time Frame

Baseline, Days 15, and 28

Title

Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Awakenings (sNAW)

Description

Time Frame

Baseline, Days 15, and 28

Title

Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Participants With Subjective Sleep Quality (sSQ) Response

Description

Time Frame

Baseline, Days 15, and 28

Title

Change From Baseline in the 36-item Short Form Survey Version 2 (SF-36v2) Physical and Mental Component Summary Scores

Description

Time Frame

Baseline, Days 15, and 42

Title

Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Total Score

Description

Time Frame

Baseline, Days 15, and 42

Title

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods

Description

Time Frame

Treatment period: Up to Day 14; FU period: Day 15 to 42

Title

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Extended FU Period

Description

Time Frame

Extended FU Period: Day 43 to 182

Title

Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods

Description

Time Frame

Treatment period: Up to Day 14; FU period: Day 15 to 42

Title

Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Extended FU Period

Description

Time Frame

Extended FU Period: Day 43 to 182

Title

Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods

Description

Time Frame

Treatment period: Up to Day 14; FU period: Day 15 to 42

Title

Number of Participants With Clinically Significant Vital Sign Abnormalities in Extended FU Period

Description

Time Frame

Extended FU Period: Day 43 to 182

Title

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods

Description

Time Frame

Treatment period: Up to Day 14; FU period: Day 15 to 42

Title

Number of Participants With Clinically Significant ECG Abnormalities in Extended FU Period

Description

Time Frame

Extended FU Period: Day 43 to 182

Title

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

Description

Time Frame

Day 42

Title

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

Description

Time Frame

Day 182

Title

Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score

Description

Time Frame

Baseline, Days 15, 18, and 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period. 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: Participant had active psychosis. Participant had attempted suicide associated with the current episode of MDD. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Facility Information:

Facility Name

Sage Investigational Site

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Sage Investigational Site

City

Bellflower

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

Sage Investigational Site

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Sage Investigational Site

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Sage Investigational Site

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

Sage Investigational Site

City

Oakland

State/Province

California

ZIP/Postal Code

94607

Country

United States

Facility Name

Sage Investigational Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92054

Country

United States

Facility Name

Sage Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Sage Investigational Site

City

Pico Rivera

State/Province

California

ZIP/Postal Code

90660

Country

United States

Facility Name

Sage Investigational Site

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

Sage Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Sage Investigational Site

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Sage Investigational Site

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Sage Investigational Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33067

Country

United States

Facility Name

Sage Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Sage Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Sage Investigational Site

City

Lauderhill

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Sage Investigational Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32750

Country

United States

Facility Name

Sage Investigational Site

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

Sage Investigational Site

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Sage Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Sage Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32807

Country

United States

Facility Name

Sage Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Sage Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Sage Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

Site Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Sage Investigational Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Facility Name

Sage Investigational Site

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Sage Investigational Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39110

Country

United States

Facility Name

Sage Investigational Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Sage Investigational Site

City

O'Fallon

State/Province

Missouri

ZIP/Postal Code

63368

Country

United States

Facility Name

Sage Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Sage Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

Sage Investigational Site

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Sage Investigational Site

City

Jamaica

State/Province

New York

ZIP/Postal Code

11432

Country

United States

Facility Name

Sage Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Sage Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

Sage Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45215

Country

United States

Facility Name

Sage Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Sage Investigational Site

City

North Canton

State/Province

Ohio

ZIP/Postal Code

44720

Country

United States

Facility Name

Sage Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73106

Country

United States

Facility Name

Sage Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Sage Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Sage Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97214

Country

United States

Facility Name

Sage Investigational Site

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Sage Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Sage Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Sage Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78754

Country

United States

Facility Name

Sage Investigational Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Sage Investigational Site

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Sage Investigational Site

City

Richardson

State/Province

Texas

ZIP/Postal Code

75080

Country

United States

Facility Name

Sage Investigational Site

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76309

Country

United States

Facility Name

Sage Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Links:

URL

http://www.sagerx.com

Description

Related Info

Learn more about this trial

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

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

Major Depressive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial