A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Summary
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).
Timeline
- Start
- 2016-11-13
- Primary completion
- 2019-02-22
- Completion
- 2019-02-22
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Rapastinel 450 mg Every 2 Weeks; p = 0.5305; Log Rank NCT02951988 ↗
registry analysis (superiority test); Placebo vs Rapastinel 450 mg Weekly; p = 0.4628; Log Rank NCT02951988 ↗
release “an interim analysis of the rapastinel relapse prevention study (RAP-MD-04) suggests the primary and key secondary endpoints will not be met.” abbvie.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rapastinel | Other / unclassified | 450 mg | Intravenous |