A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

Summary

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (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

2016-11-02

Primary completion

2018-10-26

Completion

2018-11-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Rapastinel 450 mg; p = 0.2398; Least Squares Mean Difference -1.0 (95% CI -2.70 to 0.68); NCT02943577 ↗

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	450 mg	Intravenous

Indications