Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04442490 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 543
- Enrollment target
NCT04442490: Completed Phase 3 study, sponsored by Biogen.
NCT04442490 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 543 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04442490, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 543 participants
- Enrollment target
Study Summary
The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.
Primary Outcome
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the 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 a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individ
Interventions
- DRUG Placebo
- DRUG SAGE-217
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2020-05-12 |
| Est. Completion | 2021-04-21 |
| Phase | Phase 3 |
What the finished NCT04442490 record still lists
NCT04442490 is an interventional study that assigns participants to a tested intervention. The registered 543 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 (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04442490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04442490 about?
NCT04442490 is a clinical study titled "A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)". The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.
What is the current status of trial NCT04442490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 543 participants. The study started on 2020-05-12. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT04442490?
The interventions under investigation include: Placebo (DRUG), SAGE-217 (DRUG).
Who is sponsoring clinical trial NCT04442490?
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 NCT04442490's enrollment target sits among peer trials
543 694th of 2000 higher than 1,307 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07294053 · 543 participants · NA
Sugary Drink Labeling Study
- NCT03127761 · 544 participants
Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma
- NCT04378790 · 544 participants · Phase 3
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
- NCT06118502 · 544 participants · NA
A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI