CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 513 enrolled
Drug / intervention
Aticaprant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05455684
NCT05455684Phase 3Completed

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

Janssen Research & Development, LLC·interventional·Posted Jul 13, 2022·Updated Nov 6, 2025

In Brief

A Phase 3 clinical trial evaluating Aticaprant and Placebo for Depressive Disorder, Major and Anhedonia. Completed, enrolled 513 participants across 120 sites in 13 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Czechia, Hungary, Italy, Poland, Portugal, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJul 13, 2022
Enrollment StartJun 22, 2022
Primary CompletionSep 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.0 years ago

Interventions

Aticaprantdrug

Aticaprant will be administered orally as tablets.

Placeboother

Placebo will be administered orally as tablets.