The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[SSRI\] or serotonin-norepinephrine reuptake inhibitor \[SNRI\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
Aticaprant will be administered orally.
Placebo will be administered orally.
Preferred Research Partners
Little Rock, Arkansas, United States
Wake Research PRI Encino
Encino, California, United States
Wr Pri Llc
Newport Beach, California, United States
ATP Clinical Research
Orange, California, United States
Myndful Research
Redlands, California, United States
Artemis Institute for Clinical Research
Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse
Relapse is defined as any of the following: MADRS total score \>=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prevention. Relapse date is defined by the second MADRS assessment. MADRS is a clinician-rated 10-item scale scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), with higher scores indicating more severe symptoms. C-SSRS is clinician-rated and reports severity and frequency of suicide-related ideation and behavior, categorized as no ideation/behavior (0), suicidal ideation (1 -5), or suicidal behavior (6 -10), with higher scores reflecting greater severity.
Time frame: From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])
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San Diego, California, United States
UHC Research
Doral, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
GTL Medical and Research Group
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
...and 85 more locations