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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
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511557-21-00
Acronym
67953964MDD3007
Enrollment
212
Registered
2024-10-28
Start date
2024-11-14
Completion date
2025-02-28
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia

Brief summary

Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Interventions

Sponsors

Janssen Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Countries

Belgium, Bulgaria, Czechia, Finland, Hungary, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026