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

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major, Anhedonia

In brief

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).

Key facts

Study ID: NCT05455684
Run by: Janssen Research & Development, LLC
People needed: 513
Starts: 2022-06-22
Expected to finish: 2024-09-18
Last updated by the study team: 2025-11-06

Who can join

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

You may qualify if…

Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
Have a Hamilton Depression Rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments
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). Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age
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. An inadequate response is defined as less than(<) 50% reduction in depressive symptom severity but with some improvement (>0%) (ie, there may be minimal to moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function), as assessed by the MGH ATRQ
Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine at a stable dose for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression
Participant's current major depressive episode, and antidepressant treatment response in the current depressive episode, must all be confirmed by the site independent qualification assessment

You may not qualify if…

Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI (that is, the one presumed to be continued in the treatment phase) 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 had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation device
Has current, or a history (past 6 months), of seizures
Has a current 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, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 or Item 5, or a history of suicidal behavior within the past 6 months prior to the start of the Screening Phase. Participants reporting suicidal ideation with intent to act or suicidal behavior at baseline should be excluded
Has one or more of the following diagnoses: a) A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia; b) A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c) A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders

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
Asclepes Research — Long Beach, California, United States
Excell Research Inc — Oceanside, California, United States
Syrentis Clinical Research — Santa Ana, California, United States
Viking Clinical Research Ltd — Temecula, California, United States
University of Connecticut Health Center — Farmington, Connecticut, United States
Innovative Research of West Florida, Incorporated — Clearwater, Florida, United States
Vertex Research Group, Inc — Clermont, Florida, United States
Gulfcoast Medical Research Center — Fort Myers, Florida, United States
New Life Medical Research Center, Inc. — Hialeah, Florida, United States
Amedica Research Institute Inc — Hialeah, Florida, United States
Convenient Medical Center — Hialeah, Florida, United States
Galiz Research — Hialeah, Florida, United States
Pharmax Research Clinic Inc — Miami, Florida, United States
A Plus Research — Miami, Florida, United States
Meridian International Research — Miami Gardens, Florida, United States
University of Miami — Miami Lakes, Florida, United States
Medical Research Group of Central Florida — Orange City, Florida, United States
USF, Department of Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States
Research Network America — Berwyn, Illinois, United States
C.H.U. Brugmann — Brussels, Belgium

Full record on ClinicalTrials.gov

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