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NCT03864614 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,515
- Enrollment target
NCT03864614: Completed Phase 3 study, sponsored by Biogen.
NCT03864614 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 1,515 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03864614, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,515 participants
- Enrollment target
Study Summary
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part A, a TEAE was defined as an AE with onse
Interventions
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,515 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2023-06-22 |
| Phase | Phase 3 |
What the finished NCT03864614 record still lists
NCT03864614 is an interventional study that assigns participants to a tested intervention. Its 1,515 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% higher).
The record links to 0 conditions, and to 1 intervention - of which SAGE-217 is the first listed.
NCT03864614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03864614 about?
NCT03864614 is a clinical study titled "A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)". This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
What is the current status of trial NCT03864614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,515 participants. The study started on 2019-02-27. Estimated completion is 2023-06-22.
What interventions are being tested in trial NCT03864614?
The interventions under investigation include: SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT03864614?
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 NCT03864614's enrollment target sits among peer trials
1,515 156th of 2000 higher than 1,845 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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