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

Allergan

Status and phase: Terminated; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo; Drug: Rapastinel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03614156

2018-000064-28 (EudraCT Number)

RAP-MD-33

Details and patient eligibility

About

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).

Enrollment: 363 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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363 participants in 3 patient groups, including a placebo group

Rapastinel weekly

Experimental group

Description:

Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)

Treatment:

Drug: Rapastinel

Rapastinel clinically driven schedule

Experimental group

Description:

Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)

Treatment:

Drug: Rapastinel

Placebo weekly

Placebo Comparator group

Description:

Placebo (prefilled syringe, weekly IV administration)

Treatment:

Drug: Placebo