Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)

• Status: Terminated
• Trial end date: 2019-07-11
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Criteria

Inclusion Criteria: -

• Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32

• If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria: -

• DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

• Lifetime history of meeting DSM-5 criteria for:

• 1.Schizophrenia spectrum or other psychotic disorder

• 2.Bipolar or related disorder

• 3.Major neurocognitive disorder

• 4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study

• 5.Dissociative disorder

• 6.Posttraumatic stress disorder

• 7.MDD with psychotic features

• Significant suicide risk, as judged by the Investigator