A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

Phase 2

Terminated

Brief Summary: The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

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 4 weeks and not exceeding 24 months in duration at visit 1
Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
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 1 month before Visit 1.
Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
Prior participation in any investigational study of rapastinel/GLYX-13

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo-matching rapastinel weekly IV injections.
Rapastinel 450mg	Rapastinel	Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline and 1 Day	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score	Baseline and 1 Day	The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline and 28 Days	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score	Baseline and 28 Days	The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.

Locations (17): CBH Health
🇺🇸
Gaithersburg, Maryland, United States
Collaborative NeuroScience Network, LLC
🇺🇸
Garden Grove, California, United States
Research Centers of America, LLC
🇺🇸
Oakland Park, Florida, United States
Innovative Clinical Research, Inc
🇺🇸
Hialeah, Florida, United States
Behavioral Research Specialists, LLC
🇺🇸
Glendale, California, United States
Institute of Living
🇺🇸
Hartford, Connecticut, United States
Asclepes Research Centers
🇺🇸
Panorama City, California, United States
Atlanta Center for Medical Research (ACMR)
🇺🇸
Atlanta, Georgia, United States
Lake Charles Clinical Trials
🇺🇸
Lake Charles, Louisiana, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸
Hoffman Estates, Illinois, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Pillar Clinical Research, LLC
🇺🇸
Richardson, Texas, United States
Carilion Medical Center, a Virginia Nonprofit Corporation
🇺🇸
Roanoke, Virginia, United States
Department of Veterans Affairs Salem VA Medical Center
🇺🇸
Salem, Virginia, United States
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Altea Research Institute
🇺🇸
Las Vegas, Nevada, United States
Cincinnati VA Medical Center
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Cincinnati, Ohio, United States