NCT06635135

A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure

A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (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 assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[SSRI\] or serotonin-norepinephrine reuptake inhibitor \[SNRI\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.

Conditions

• Depressive Disorder, Major
• Anhedonia

Interventions

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

Timeline

• Start date: 2024-09-19
• Primary completion: 2025-04-09
• Completion: 2025-04-25
• First posted: 2024-10-10
• Last updated: 2026-03-12

Locations

95 sites across 13 countries: United States, Argentina, Belgium, Brazil, Bulgaria, France, Germany, Greece, Mexico, Poland, Romania, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study