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

Phase 3

Completed

Brief 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo-matching Rapastinel	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
Rapastinel 450 mg Weekly	Rapastinel	Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
Rapastinel 450 mg Every 2 Weeks	Rapastinel	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.

Primary Outcome Measures

Name	Time	Method
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period	52 Weeks	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	104 Weeks	On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"

Secondary Outcome Measures

Name	Time	Method
Time to First Relapse During the Entire Double-Blind Treatment Period	104 Weeks	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

Locations (131): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Harmonex Neuroscience Research
🇺🇸
Dothan, Alabama, United States
NoesisPharma
🇺🇸
Phoenix, Arizona, United States
University of Arizona Department of Psychiatry
🇺🇸
Tucson, Arizona, United States
Woodland International Research Group
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Little Rock, Arkansas, United States
Woodland Research Northwest
🇺🇸
Rogers, Arkansas, United States
California Pharmaceutical Research Institute, Inc
🇺🇸
Anaheim, California, United States
Southern California Research LLC.
🇺🇸
Beverly Hills, California, United States
ATP Clinical Research Inc.
🇺🇸
Costa Mesa, California, United States
ProScience Research Group
🇺🇸
Culver City, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States