A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (VENTURA-1)
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as
adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+)
who have had an inadequate response to current antidepressant therapy with a selective
serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Depression is a common and serious psychiatric disorder which is a leading cause of
disability worldwide and is associated with elevated mortality and suicide risk. Aticaprant
(JNJ-67953964) is a once daily, highly selective kappa opioid receptor (KOR) antagonist, with
demonstrated selectivity over mu opioid receptor (MOR) and delta opioid receptor (DOR) being
developed for adjunctive treatment of major depressive disorder (MDD) with moderate-to-severe
anhedonia (ANH+). The study consists of a screening phase (up to 30 days prior to
randomization), double-blind treatment phase (43 days), and follow-up phase (up to 14 days).
The total duration of the study will be up to 87 days. Safety evaluations including adverse
events, physical examinations, urine drug test, alcohol breath tests, and clinical laboratory
tests will be assessed at specific time points during this study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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