drugset / Trial / NCT05550532

A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

NCT05550532 ↗

Phase 3 Completed 444 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start
2022-12-06
Primary completion
2024-11-08
Completion
2024-11-13

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Aticaprant 10 mg; p =0.670; Least Square Mean Difference -0.5 (95% CI -2.95 to 1.90); NCT05550532 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aticaprant Small molecule 10 mg Oral