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NCT06514742 | RECRUITING | Depressive Disorder, Major

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
Sponsor:

Janssen Research & Development, LLC

Brief 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).

Condition or disease

Depressive Disorder, Major

Anhedonia

Intervention/treatment

Aticaprant

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 350 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability 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 an Open Label Long-term Extension Treatment With Aticaprant
Actual Study Start Date : 2024-06-26
Estimated Primary Completion Date : 2026-06-17
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 double blind (DB) 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 (DSM-5 296.22, 296.23, 296.32, or 296.33), based upon clinical assessment and confirmed by the structured clinical interview for 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 MDE module symptom Item 2) on the SCID-CT at screening
  • * Have had an inadequate response to at least 1 and up to 5 (inclusive) oral antidepressant treatments, administered at an adequate dose
  • * Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI) antidepressants at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, or desvenlafaxine at a stable dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire (MGH ATRQ) for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression
Exclusion Criteria
  • * Has had no response (treatment failure) to 2 or more consecutive antidepressant treatments administered at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current episode of depression including the current SSRI/SNRI (that is the one to be continued in the treatment phases) assessed using the MGH ATRQ
  • * Has one or more of the following diagnoses: (1) a current or prior (lifetime) DSM-5 diagnosis of: (a) a psychotic disorder or MDD with psychotic features, (b) bipolar or related disorders, (c) intellectual disability, (d) autism spectrum disorder, (e) borderline personality disorder, (f) antisocial personality disorder, (g) histrionic personality disorder, (h) narcissistic personality disorders, (i) somatoform disorders; (2) A primary DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of: (a) panic disorder, (b) generalized anxiety disorder, (c) social anxiety disorder, (d) specific phobia; (3) A current (in the past year) DSM-5 diagnosis of: (a) obsessive-compulsive disorder, (b) post-traumatic stress disorder, (c) anorexia nervosa, (d) bulimia nervosa
  • * 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 in the current depressive episode had vagal nerve stimulation or deep brain stimulation device in the current episode or has had an inadequate response to an adequate course of intravenous or intranasal ketamine or esketamine (greater than \[\>\] 2 treatments), or electroconvulsive therapy (that is at least 7 treatments)
  • * 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, per the investigator's clinical judgment or based on the columbia suicidality severity rating scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, 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 DB baseline should be excluded
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

Location Details

NCT06514742

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

IMA Clinical Research PC

Phoenix, arizona, United States, 85012

RECRUITING

United States, Arizona

Noble Clinical Research

Tucson, arizona, United States, 85704

RECRUITING

United States, California

Advanced Research Center Inc

Anaheim, California, United States, 92805

RECRUITING

United States, California

CI Trials

Bellflower, California, United States, 90706

RECRUITING

United States, California

Behavioral Research Specialists LLC

Glendale, California, United States, 91206

RECRUITING

United States, California

Sun Valley Research Center

Imperial, California, United States, 92251

RECRUITING

United States, California

ATP Clinical Research

Orange, California, United States, 92868

RECRUITING

United States, California

Lumos Clinical Research Center LLC

San Jose, California, United States, 95124

RECRUITING

United States, California

Viking Clinical Research Ltd

Temecula, California, United States, 92591

RECRUITING

United States, Florida

Humanity Clinical Research Corp

Aventura, Florida, United States, 33180

RECRUITING

United States, Florida

Elligo Independent Research Sites Mindful Behavioral Health

Boca Raton, Florida, United States, 33431

RECRUITING

United States, Florida

Gulfcoast Medical Research Center

Fort Myers, Florida, United States, 33912

RECRUITING

United States, Florida

Medquest Translational Sciences

Miami Lakes, Florida, United States, 33016

RECRUITING

United States, Florida

Best Choice Medical and Research Service

Pembroke Pines, Florida, United States, 33024

RECRUITING

United States, Florida

K2 Medical Research

Tampa, Florida, United States, 33607

RECRUITING

United States, Georgia

Accelerated Clinical Trials LLC

Peachtree Corners, Georgia, United States, 30071

RECRUITING

United States, Illinois

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

RECRUITING

United States, Louisiana

DelRicht Research

New Orleans, Louisiana, United States, 70115

RECRUITING

United States, New York

Integrative Clinical Trials LLC

Brooklyn, New York, United States, 11229

RECRUITING

United States, New York

Fieve Clinical Research Inc

New York, New York, United States, 10017

RECRUITING

United States, Ohio

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States, 45215

RECRUITING

United States, Pennsylvania

Suburban Research Associates

Media, Pennsylvania, United States, 19063

RECRUITING

United States, Texas

Brain Health Consultants

Houston, Texas, United States, 77046

RECRUITING

United States, Texas

Red Oak Psychiatry Associates

Houston, Texas, United States, 77090

RECRUITING

United States, Texas

Perceptive Pharma Research

Richmond, Texas, United States, 77407

RECRUITING

United States, Texas

Revival Research Institute LLC

Sherman, Texas, United States, 75092