Phase 2
N=21
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
Severe Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT02614547 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score — -8.75; -20.97 score on a scale — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAGE-547 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score |
-8.75; -20.97 | 0.008 sig |
| SECONDARY Percentage of Participants With HAM-D Response |
36.4; 70.0; 20.0; 80.0; 27.3; 70.0 | 0.198 |
| SECONDARY Percentage of Participants With HAM-D Remission |
9.1; 70.0; 0.0; 70.0; 18.2; 70.0 | 0.008 sig |
| SECONDARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-12.10; -27.96; -11.60; -27.56; -11.19; -26.26 | 0.010 sig |
| SECONDARY Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response |
36.4; 80.0; 20.0; 80.0; 27.3; 80.0 | 0.080 |
| SECONDARY Change From Baseline in HAM-D Bech 6 Subscale |
-4.89; -10.94; -3.99; -10.44; -3.34; -10.14 | 0.025 sig |
| SECONDARY Change From Baseline to 60 Hours in the HAM-D Individual Item Scores |
-1.4; -2.5; -0.5; -1.7; -0.4; -1.1 | — |
| SECONDARY Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score |
-9.08; -7.21; -7.96; -9.44; -7.38; -9.48 | 0.457 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
8; 4 | — |
Summary
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.
Eligibility Criteria
Key Inclusion Criteria
- Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
- Participant 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 DSM-IV Axis I Disorders (SCID-I).
- Participant was less than or equal to (<=) six months postpartum.
- Participant must be amenable to intravenous therapy.
Key Exclusion Criteria
- Active psychosis.
- Attempted suicide associated with index case of postpartum depression.
- Medical history of seizures.
- Medical history of bipolar disorder.
Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02614547). 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.