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NCT04442503 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT04442503: Completed Phase 3 study, sponsored by Biogen.
NCT04442503 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04442503, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypo
Interventions
- DRUG Placebo
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2022-04-12 |
| Phase | Phase 3 |
What the finished NCT04442503 record still lists
NCT04442503 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04442503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04442503 about?
NCT04442503 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)". 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.
What is the current status of trial NCT04442503?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2020-06-08. Estimated completion is 2022-04-12.
What interventions are being tested in trial NCT04442503?
The interventions under investigation include: Placebo (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT04442503?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04442503's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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