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

Allergan

Status and phase

Completed

Phase 3

Conditions

Depressive Disorder, Major

Treatments

Drug: Rapastinel

Study type

Interventional

Funder types

Industry

Identifiers

NCT03002077

RAP-MD-06

Details and patient eligibility

About

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).

Enrollment

617 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.