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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Rapastinel pre-filled syringes for weekly IV injections.
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States
Collaborative NeuroScience Network, LLC
Garden Grove, California, United States
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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.
Time frame: Baseline and 1 Day
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
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.
Time frame: Baseline and 1 Day
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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.
Time frame: Baseline and 28 Days
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
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.
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Behavioral Research Specialists, LLC
Glendale, California, United States
Asclepes Research Centers
Panorama City, California, United States
Institute of Living
Hartford, Connecticut, United States
Innovative Clinical Research, Inc
Hialeah, Florida, United States
Research Centers of America, LLC
Oakland Park, Florida, United States
Atlanta Center for Medical Research (ACMR)
Atlanta, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
...and 7 more locations
Time frame: Baseline and 28 Days