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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,304
Rapastinel pre-filled syringes for IV injections.
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Time frame: 52 Weeks
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
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"
Time frame: 104 Weeks
Time to First Relapse During the Entire Double-Blind Treatment Period
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Time frame: 104 Weeks
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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
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
...and 127 more locations