NCT05518149

A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 871 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Aticaprant	Aticaprant 10 mg tablet will be administered orally.

Timeline

• Start date: 2022-09-22
• Primary completion: 2025-04-25
• Completion: 2025-05-08
• First posted: 2022-08-26
• Last updated: 2026-04-15

Locations

234 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Hungary, Italy, Poland, Portugal, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study