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NCT04007367 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT04007367: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT04007367 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04007367, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).
Primary Outcome
Time to relapse was defined as days from the first dose of the study drug in the DB Phase to the day of relapse during the DB Phase. Participant was considered to have relapsed if: 2 consecutive HAM-D scores were ≥ 18 assessed 7 to 14 days apart, any worsening of depression requiring hospitalization, Investigator-determined risk of suicide, or any other clinically relevant event whether or not hospitalization was required. HAM-D is a scale used to rate depression in participants who were already
Interventions
- DRUG Placebo
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-08-06 |
| Est. Completion | 2020-01-06 |
| Phase | Phase 3 |
Why NCT04007367 stopped before completion
NCT04007367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04007367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04007367 about?
NCT04007367 is a clinical study titled "A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder". This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).
What is the current status of trial NCT04007367?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2019-08-06. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT04007367?
The interventions under investigation include: Placebo (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT04007367?
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 NCT04007367's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 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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