A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

November 27, 2023 updated by: Biogen

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression

The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Sage Investigational Site
    • California
      • Beverly Hills, California, United States, 90212
        • Sage Investigational Site
      • Oceanside, California, United States, 92056
        • Sage Investigational Site
      • Wildomar, California, United States, 92595
        • Sage Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Sage Investigational Site
    • Florida
      • Aventura, Florida, United States, 33027
        • Sage Investigational Site
      • Miami, Florida, United States, 33173
        • Sage Investigational Site
      • Orlando, Florida, United States, 32807
        • Sage Investigational Site
      • Pensacola, Florida, United States, 32502
        • Sage Investigational Site
      • Pinellas Park, Florida, United States, 33782
        • Sage Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Sage Investigational Site
      • Decatur, Georgia, United States, 30030
        • Sage Investigational Site
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Sage Investigational Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Sage Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Sage Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Sage Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Sage Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Sage Investigational Site
    • New York
      • Manhasset, New York, United States, 11030
        • Sage Investigational Site
      • New York, New York, United States, 10036
        • Sage Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Sage Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • Sage Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Sage Investigational Site
    • Texas
      • Fort Worth, Texas, United States, 76060
        • Sage Investigational Site
      • Houston, Texas, United States, 77058
        • Sage Investigational Site
      • Richardson, Texas, United States, 75080
        • Sage Investigational Site
    • Utah
      • Orem, Utah, United States, 84058
        • Sage Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)
  • Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
  • Participant was <=six months postpartum.

Key Exclusion Criteria:

  • Active psychosis
  • Attempted suicide associated with current episode of postpartum depression
  • Medical history of seizures
  • Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria might apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: SAGE-217 15/20 mg Oral Solution
Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
Drug: SAGE-217 15/20 mg Oral Solution
SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).
Placebo Comparator: Part B: Placebo
Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
Drug: Placebo
SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
Experimental: Part B: SAGE 217 30 mg Capsules
Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Drug: SAGE 217 30 mg Capsules
SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
Time Frame: Parts A and B: Baseline, Day 15
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 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. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Parts A and B: Baseline, Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45
Time Frame: Part B: Baseline, Days 3, 8, 21 and 45
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 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. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Part B: Baseline, Days 3, 8, 21 and 45
Parts A and B: Percentage of Participants With HAM-D Response
Time Frame: Part B: Days 3, 8, 15, 21 and 45
HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.
Part B: Days 3, 8, 15, 21 and 45
Parts A and B: Percentage of Participants With HAM-D Remission
Time Frame: Part B: Days 3, 8, 15, 21 and 45
HAM-D Remission was defined as a HAM-D total score of less than or equal to (<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.
Part B: Days 3, 8, 15, 21 and 45
Parts A and B: Change From Baseline in HAM-D Subscales Scores
Time Frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety [psychic and somatic], somatic symptoms [gastrointestinal and general], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Part B: Baseline, Days 3, 8, 15, 21 and 45
Parts A and B: Change From Baseline in HAM-D Individual Item Scores
Time Frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were 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. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.
Part B: Baseline, Days 3, 8, 15, 21 and 45
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Part B: Baseline, Days 3, 8, 15, 21 and 45
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Time Frame: Part B: Days 3, 8, 15, 21 and 45
The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.
Part B: Days 3, 8, 15, 21 and 45
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time Frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of <17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.
Part B: Baseline, Days 3, 8, 15, 21 and 45
Parts A and B: Percentage of Participants With MADRS Response
Time Frame: Part B: Days 3, 8, 15, 21 and 45
MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.
Part B: Days 3, 8, 15, 21 and 45
Parts A and B: Percentage of Participants With MADRS Remission
Time Frame: Part B: Days 3, 8, 15, 21 and 45
MADRS Remission was defined as a MADRS total score of <=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.
Part B: Days 3, 8, 15, 21 and 45
Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Part A: Up to Day 75; Part B: Up to Day 45
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
Part A: Up to Day 75; Part B: Up to Day 45
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Time Frame: Part B: From first dose of study drug up to 45 days
Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.
Part B: From first dose of study drug up to 45 days
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations
Time Frame: Part B: From first dose of study drug up to 45 days
Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.
Part B: From first dose of study drug up to 45 days
Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate
Time Frame: Part B: Baseline, Days 8, 15, and 21
ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.
Part B: Baseline, Days 8, 15, and 21
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval
Time Frame: Part B: Baseline, Days 8, 15, and 21
ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.
Part B: Baseline, Days 8, 15, and 21
Part B: Number of Participants With a Response of "Yes" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Part B: Up to Day 45
C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.
Part B: Up to Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Actual)

November 15, 2018

Study Completion (Actual)

December 11, 2018

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimated)

November 30, 2016

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217-PPD-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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