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

Allergan

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo-matching Rapastinel; Drug: Rapastinel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02951988

RAP-MD-04

Details and patient eligibility

About

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).

Enrollment: 1,304 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,304 participants in 3 patient groups, including a placebo group

Rapastinel 450 mg Weekly

Experimental group

Description:

Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.

Treatment:

Drug: Rapastinel

Rapastinel 450 mg Every 2 Weeks

Experimental group

Description:

Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.

Treatment:

Drug: Rapastinel

Placebo

Placebo Comparator group

Description:

Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.

Treatment:

Drug: Placebo-matching Rapastinel