Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2018-12-06
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).

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

Details

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

Criteria

Inclusion Criteria:

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD

• Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening

• Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant

• 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 Screening

• Lifetime history of meeting DSM-5 criteria for:

• Schizophrenia spectrum or other psychotic disorder

• Bipolar or related disorder

• Major neurocognitive disorder

• 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

• Dissociative disorder

• Posttraumatic stress disorder

• MDD with psychotic features

• Significant suicide risk, as judged by the Investigator.