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NCT04476030 · ClinicalTrials.gov registry record · Phase 3
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
NCT04476030: Completed Phase 3 study, sponsored by Biogen.
NCT04476030 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 440 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04476030, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
Primary Outcome
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging f
Interventions
- DRUG Escitalopram
- DRUG Matching Placebo
- DRUG Sertraline
- DRUG Citalopram
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2021-12-22 |
| Phase | Phase 3 |
What the finished NCT04476030 record still lists
NCT04476030 is an interventional study that assigns participants to a tested intervention. The registered 440 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 (43% lower).
The record links to 0 conditions, and to 5 interventions - of which Escitalopram is the first listed.
NCT04476030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04476030 about?
NCT04476030 is a clinical study titled "A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder". The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
What is the current status of trial NCT04476030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2020-11-09. Estimated completion is 2021-12-22.
What interventions are being tested in trial NCT04476030?
The interventions under investigation include: Escitalopram (DRUG), Matching Placebo (DRUG), Sertraline (DRUG), Citalopram (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT04476030?
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 NCT04476030's enrollment target sits among peer trials
440 867th of 2000 higher than 1,129 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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