Overview

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

Status:
Completed
Trial end date:
2019-02-22
Target enrollment:
0
Participant gender:
All
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).
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.