Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02218008 · ClinicalTrials.gov registry record · Phase 3
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT02218008: Completed Phase 3 study, sponsored by Alkermes.
NCT02218008 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 407 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02218008, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of ALKS 5461.
Primary Outcome
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Interventions
- DRUG Placebo
- DRUG ALKS 5461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02218008 record still lists
NCT02218008 is an interventional study that assigns participants to a tested intervention. The registered 407 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02218008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02218008 about?
NCT02218008 is a clinical study titled "A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study". This study will evaluate the efficacy and safety of ALKS 5461.
What is the current status of trial NCT02218008?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2014-07. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02218008?
The interventions under investigation include: Placebo (DRUG), ALKS 5461 (DRUG).
Who is sponsoring clinical trial NCT02218008?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02218008's enrollment target sits among peer trials
407 913th of 2000 higher than 1,088 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
- NCT06735534 · 407 participants · NA
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
- NCT07094516 · 407 participants · Phase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
- NCT04835428 · 408 participants · NA
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
- NCT05836324 · 408 participants · Phase 1
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia