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A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

NCT05550532 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2026-02-13

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (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
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2024-11-08
Completion
2024-11-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Poland
  • Slovakia
  • South Africa
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05550532 on ClinicalTrials.gov