Phase 3
N=1
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT02978326 ↗Enrolled (actual)
1
Serious AEs
1.3%
Results posted
Dec 2021
Primary outcome: Primary: Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 — -13.6; -17.8 score on a scale — p=0.0028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SAGE-217 15/20 mg Oral Solution (Drug); Placebo (Drug); SAGE 217 30 mg Capsules (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Biogen
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 |
-13.6; -17.8 | 0.0028 sig |
| SECONDARY Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 |
-9.8; -12.5; -12.9; -16.3; -14.4; -17.6 | 0.0252 sig |
| SECONDARY Parts A and B: Percentage of Participants With HAM-D Response |
27.0; 40.5; 44.6; 65.3; 47.9; 71.6 | 0.1004 |
| SECONDARY Parts A and B: Percentage of Participants With HAM-D Remission |
5.4; 18.9; 18.9; 32.0; 23.3; 44.6 | 0.0200 sig |
| SECONDARY Parts A and B: Change From Baseline in HAM-D Subscales Scores |
-16.7; -18.8; -23.4; -28.7; -26.8; -31.9 | 0.3832 |
| SECONDARY Parts A and B: Change From Baseline in HAM-D Individual Item Scores |
-0.8; -1.1; -1.3; -1.7; -1.5; -1.8 | 0.1569 |
| SECONDARY Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score |
-11.7; -14.8; -16.3; -20.3; -17.6; -22.1 | 0.0791 |
| SECONDARY Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response |
28.4; 37.8; 50.0; 65.3; 52.1; 71.6 | 0.3372 |
| SECONDARY Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score |
-8.9; -12.0; -11.7; -16.1; -12.7; -16.6 | 0.0169 sig |
| SECONDARY Parts A and B: Percentage of Participants With MADRS Response |
27.0; 40.5; 50.0; 64.0; 47.9; 73.0 | 0.1145 |
| SECONDARY Parts A and B: Percentage of Participants With MADRS Remission |
9.5; 24.3; 28.4; 37.3; 30.1; 54.1 | 0.0326 sig |
| SECONDARY Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
1; 38; 47 | — |
| SECONDARY Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements |
0; 3; 2; 1; 1; 0 | — |
| SECONDARY Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations |
0; 1; 11; 8; 10; 12 | — |
| SECONDARY Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate |
68.2; 69.9; 0.8; 1.5; -0.1; 0.9 | — |
| SECONDARY Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval |
151.4; 151.7; 3.4; 0.6; 1.1; 0.8 | — |
| SECONDARY 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) |
13; 6; 0; 0 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02978326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.