This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
658
Rapastinel pre-filled syringes for weekly IV injections.
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
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 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 3 Weeks
Change From Baseline in 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 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 Day 8
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Department of Psychiatry
Tucson, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
California Pharmaceutical Research Institute, Inc
Anaheim, California, United States
ProScience Research Group
Culver City, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Synergy Clinical Research Center of Escondido
Lemon Grove, California, United States
Pacific Research Partners; LLC.
Oakland, California, United States
CITrials
Riverside, California, United States
...and 56 more locations