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NCT03771664 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT03771664: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT03771664 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03771664, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
Primary Outcome
Sleep Efficiency (SE) is the percentage of time in bed spent asleep, determined during an 8-hour overnight PSG recording. The PSG measures the physiological process of sleep by monitoring body functions including brain waves, eye movements, muscle activity or skeletal muscle activation, heart rhythm, blood oxygen saturation, and breathing functions. Stages of sleep include rapid eye movement (REM), non-rapid eye movement (NREM), NREM stage 1 (N1), NREM stage 2 (N2), and NREM stage 3 (N3), scored
Interventions
- DRUG Placebo
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2020-01-17 |
| Phase | Phase 3 |
Why NCT03771664 stopped before completion
NCT03771664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03771664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03771664 about?
NCT03771664 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia". This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
What is the current status of trial NCT03771664?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2019-02-04. Estimated completion is 2020-01-17.
What interventions are being tested in trial NCT03771664?
The interventions under investigation include: Placebo (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT03771664?
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 NCT03771664's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 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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