NCT02951988

A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,304 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Rapastinel	Rapastinel pre-filled syringes for IV injections.
DRUG	Placebo-matching Rapastinel	Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Timeline

• Start date: 2016-11-13
• Primary completion: 2019-02-22
• Completion: 2019-02-22
• First posted: 2016-11-01
• Last updated: 2020-03-09
• Results posted: 2020-03-09

Locations

137 sites across 1 country: United States

Regulatory

• FDA-regulated drug study