Stopped: The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025)
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants with Adverse Events (AEs)
Timeframe: Up to Week 54
Number of Participants with Adverse Events of Special Interest (AESI)
Timeframe: Up to Week 54
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Timeframe: Up to Week 54
Number of Participants with Abnormal Body Weight
Timeframe: Up to Week 54
Number of Participants with Abnormal Body Mass Index (BMI)
Timeframe: Up to Week 54
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Up to Week 54
Number of Participants with Abnormalities in Clinical Laboratory parameters
Timeframe: Up to Week 54
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Timeframe: Up to Week 54
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
Timeframe: Up to Week 54
Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
Timeframe: Up to Week 54