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NCT03000530 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT03000530: Completed Phase 2 study, sponsored by Biogen.
NCT03000530 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03000530, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
Primary Outcome
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part A of the study.
Interventions
- DRUG Placebo
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2017-11-08 |
| Phase | Phase 2 |
What the finished NCT03000530 record still lists
NCT03000530 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03000530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03000530 about?
NCT03000530 is a clinical study titled "A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder". This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
What is the current status of trial NCT03000530?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2016-12-07. Estimated completion is 2017-11-08.
What interventions are being tested in trial NCT03000530?
The interventions under investigation include: Placebo (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT03000530?
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 NCT03000530's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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