Phase 3
N=200
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
Depression, Postpartum
Bottom Line
View on ClinicalTrials.gov: NCT04442503 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 — 28.8; 28.6; -11.4; -15.6 score on a scale — p=0.0007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SAGE-217 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Biogen
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 |
28.8; 28.6; -11.4; -15.6 | 0.0007 sig |
| SECONDARY Change From Baseline in the 17-item HAM-D Total Score |
28.8; 28.6; -6.3; -9.5; -13.5; -16.3 | 0.0008 sig |
| SECONDARY Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score |
4.9; 5.0; -1.6; -2.2 | 0.0052 sig |
| SECONDARY Percentage of Participants With HAM-D Response |
38.9; 57.0; 54.1; 61.9 | 0.0209 sig |
| SECONDARY Percentage of Participants With HAM-D Remission |
16.7; 26.9; 29.4; 44.0 | 0.1110 |
| SECONDARY Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response |
46.7; 66.7 | 0.0089 sig |
| SECONDARY Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
24.7; 24.4; -10.4; -13.0 | 0.0235 sig |
| SECONDARY Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score |
35.0; 35.5; -14.1; -19.9 | 0.0034 sig |
| SECONDARY Change From Baseline in HAM-D Subscale |
47.6; 49.2; -20.4; -27.7; 52.6; 51.2 | 0.0151 sig |
| SECONDARY Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score |
20.0; 21.1; -2.2; -4.2; -6.0; -8.9 | — |
| SECONDARY Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score |
-2.3; -2.0; -5.9; -7.7; -8.6; -10.5 | 0.6912 |
| SECONDARY Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) |
53.1; 66.3 | — |
Summary
The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
- 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 Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
- Participant is ≤12 months postpartum at screening and Day 1.
Exclusion Criteria
- Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
- Participant has active psychosis per investigator assessment.
- Participant has a medical history of nonfebrile seizures.
- Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Participant has a history of sleep apnea.
Note: Other protocol-defined inclusion/exclusion criteria applied.
Data sourced from ClinicalTrials.gov (NCT04442503). 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.