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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Rapastinel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapastinel weekly<br>Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) | Drug: Rapastinel<br>* Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)<br>|
| Experimental: Rapastinel clinically driven schedule<br>Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) | Drug: Rapastinel<br>* Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)<br>|
| Placebo Comparator: Placebo weekly<br>Placebo (prefilled syringe, weekly IV administration) | Drug: Placebo<br>* Placebo (prefilled syringe, weekly IV administration)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP) | The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse. | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression