NCT06514742

A Study 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 and Long-term Extension Treatment With Aticaprant

A Randomized, Double-blind, Multicenter, 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 and an Open Label Long-term Extension Treatment With Aticaprant

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

Conditions

• Depressive Disorder, Major
• Anhedonia

Interventions

Type	Name	Description
DRUG	Aticaprant	Aticaprant tablet will be administered orally.
OTHER	Placebo	Placebo tablet will be administered orally.

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-04-08
• Completion: 2025-04-24
• First posted: 2024-07-23
• Last updated: 2026-02-17

Locations

84 sites across 9 countries: United States, Belgium, Brazil, Bulgaria, Finland, Hungary, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study