A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
Summary
This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Timeline
- Start
- 2016-11-01
- Primary completion
- 2018-12-12
- Completion
- 2018-12-18
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Rapastinel 225 mg; p = 0.8862; Least Squares Mean Difference 0.1 (95% CI -1.50 to 1.73); Mixed Model Repeated Measures (MMRM) NCT02943564 ↗
registry analysis (superiority test); Rapastinel 225 mg vs Rapastinel 450 mg; p = 0.5772; Least Squares Mean Difference -0.5 (95% CI -2.07 to 1.16); Mixed Model Repeated Measures (MMRM) NCT02943564 ↗
release “In three acute studies (RAP-MD-01,-02,-03), the rapastinel treatment arms did not differentiate from placebo on the primary and key secondary endpoints.” abbvie.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rapastinel | Other / unclassified | 225 mg | Intravenous |
| Subject | Rapastinel | Other / unclassified | 450 mg | Intravenous |