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

Stopped early · Phase 3

Conditions studied: Depressive Disorder, Major

In brief

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).

Key facts

Study ID

NCT05518149

Run by

Janssen Research & Development, LLC

People needed

871

Starts

2022-09-22

Expected to finish

2025-05-08

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Transferred-entry participants:
• Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study
• Direct-entry participants:
• Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
• Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression
• Must be an outpatient at open-label treatment phase baseline
• Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
• Direct-entry and Transferred-entry Participants:
• Participants should not take any prohibited medication or food supplements

You may not qualify if…

• Transferred-entry Participants:
• Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
• Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments
• Direct-entry Participants:
• Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
• Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
• Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients

Where it is running

• SW Biomedical Research LLC — Tucson, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Advanced Research Center Inc — Anaheim, California, United States
• Proscience Research Group — Culver City, California, United States
• Behavioral Research Specialists LLC — Glendale, California, United States
• Sunwise Clinical Research — Lafayette, California, United States
• Asclepes Research — Long Beach, California, United States
• Excell Research Inc — Oceanside, California, United States
• Pacific Neuropsychiatric Specialists — Orange, California, United States
• Prospective Research Innovations Inc — Rancho Cucamonga, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• CMB Clinical Trials — Santee, California, United States
• California Neuroscience Research — Sherman Oaks, California, United States
• Viking Clinical Research Ltd — Temecula, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Next Level Clinical Trials, LLC — West Covina, California, United States
• MCB Clinical Research Centers LLC — Colorado Springs, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Innovative Research of West Florida, Incorporated — Clearwater, Florida, United States
• CNS Clinical Research Group — Coral Springs, Florida, United States
• Gulfcoast Medical Research Center — Fort Myers, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• New Life Medical Research Center, Inc. — Hialeah, Florida, United States
• University of Alabama at Birmingham - The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.