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
NCT06514742 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2026-02-17
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
- DRUG
-
Aticaprant
Aticaprant tablet will be administered orally.
- OTHER
-
Placebo
Placebo tablet will be administered orally.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-26
- Primary Completion
- 2025-04-08
- Completion
- 2025-04-24
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Brazil
- Bulgaria
- Finland
- Hungary
- Poland
- Spain
- Sweden
Study Locations
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