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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major, Anhedonia

In brief

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.

Key facts

Study ID

NCT06635135

Run by

Janssen Research & Development, LLC

People needed

47

Starts

2024-09-19

Expected to finish

2025-04-25

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and OL baseline
• Be medically stable based on clinical laboratory tests performed at screening
• Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) Axis I Disorders-Clinical Trials version (SCID-CT)
• Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening

You may not qualify if…

• Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)
• Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
• Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
• Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase
• Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements

Where it is running

• Wake Research PRI Encino — Encino, California, United States
• Wr Pri Llc — Newport Beach, California, United States
• ATP Clinical Research — Orange, California, United States
• Myndful Research — Redlands, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• UHC Research — Doral, Florida, United States
• Pharmax Research Clinic Inc — Miami, Florida, United States
• GTL Medical and Research Group — Miami, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Harmony Clinical Research Inc — North Miami Beach, Florida, United States
• APG Research LLC — Orlando, Florida, United States
• Interventional Psychiatry of Tampa Bay — Tampa, Florida, United States
• Synexus Clinical Research US Inc — Atlanta, Georgia, United States
• Chicago Research Center — Chicago, Illinois, United States
• Psychiatric Medicine Associates LLC — Skokie, Illinois, United States
• Continental Clinical Solutions — Towson, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• IMA Clinical Research PC — Albuquerque, New Mexico, United States
• Integrative Clinical Trials LLC — Brooklyn, New York, United States
• Bioscience Research LLC — Mount Kisco, New York, United States
• Patient Priority Clinical Sites LLC — Cincinnati, Ohio, United States
• Insight Clinical Trials — Independence, Ohio, United States
• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States
• Preferred Research Partners — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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