Phase 3
N=138
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT02942004 ↗Enrolled (actual)
138
Serious AEs
0.8%
Results posted
Jun 2019
Primary outcome: Primary: Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score — -14.04; -19.54; -17.72 score on a scale — p=0.0013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); SAGE-547 60 μg/kg/h (Drug); SAGE-547 90 μg/kg/h (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score |
-14.04; -19.54; -17.72 | 0.0013 sig |
| SECONDARY Change From Baseline in HAM-D Total Score at Day 30 |
-13.82; -19.45; -17.62 | 0.0044 sig |
| SECONDARY Change From Baseline in HAM-D Total Score |
-5.04; -4.99; -4.89; -6.88; -8.99; -7.18 | 0.9591 |
| SECONDARY Percentage of Participants With HAM-D Response |
55.8; 86.5; 74.4; 48.8; 68.4; 52.5 | 0.0052 sig |
| SECONDARY Percentage of Participants With HAM-D Remission |
16.3; 51.4; 30.8; 30.2; 31.6; 20.0 | 0.0011 sig |
| SECONDARY Change From Baseline in HAM-D Bech 6 Subscale |
-32.60; -44.67; -38.49; -29.43; -38.52; -31.67 | 0.0058 sig |
| SECONDARY Change From Baseline in HAM-D Individual Item Scores |
-0.54; -0.54; -0.45; -0.79; -0.97; -0.79 | 0.9681 |
| SECONDARY Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-19.98; -26.84; -24.19; -19.01; -23.31; -20.32 | 0.0054 sig |
| SECONDARY Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response |
55.8; 83.8; 82.1; 46.5; 71.1; 64.1 | 0.0131 sig |
| SECONDARY Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score |
-6.95; -8.08; -7.99; -6.57; -9.13; -6.32 | 0.4389 |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events |
51.2; 50.0; 53.7 | — |
| SECONDARY Time to Change in Antidepressant Medication |
16; 12; 8; 29; 19 | — |
Summary
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.
Eligibility Criteria
Key Inclusion Criteria
- Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion
- Participants 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 had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)
- Participant was ≤6 months postpartum at screening
- Participant was amenable to IV therapy
Key Exclusion Criteria
- Active psychosis
- Attempted suicide associated with index case of postpartum depression
- Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.
Note: Other protocol-defined inclusion/exclusion criteria applied.
Data sourced from ClinicalTrials.gov (NCT02942004). 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.