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NCT03672175 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 581
- Enrollment target
NCT03672175: Completed Phase 3 study, sponsored by Biogen.
NCT03672175 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 581 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03672175, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 581 participants
- Enrollment target
Study Summary
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
Primary Outcome
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retard
Interventions
- DRUG Placebo
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2020-03-17 |
| Phase | Phase 3 |
What the finished NCT03672175 record still lists
NCT03672175 is an interventional study that assigns participants to a tested intervention. The registered 581 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 (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03672175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03672175 about?
NCT03672175 is a clinical study titled "A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder". This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
What is the current status of trial NCT03672175?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 581 participants. The study started on 2018-11-19. Estimated completion is 2020-03-17.
What interventions are being tested in trial NCT03672175?
The interventions under investigation include: Placebo (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT03672175?
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 NCT03672175's enrollment target sits among peer trials
581 656th of 2000 higher than 1,345 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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