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
- Conditions
- AnhedoniaDepressive Disorder, Major
- Interventions
- Other: Placebo
- Registration Number
- NCT06514742
- Lead 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aticaprant Aticaprant - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Baseline to Day 43 Change from baseline to Day 43 in MADRS total score will be reported.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score Baseline to Day 43 Change from baseline to Day 43 in DARS total score will be reported.
Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score Baseline to Day 43 Change from baseline to Day 43 in CSFQ-14 total score will be reported.
Change From Baseline Over Time in MADRS Total Score For double-blind (DB) treatment phase: Baseline (Day 1), Up to Day 43; For open-label (OL) treatment phase: Baseline (Day 43), Up to Week 31 Change from baseline over time in the MADRS total score will be reported.
Percentage of responders on Depressive Symptoms Scale, Defined as a Greater Than or Equal to (>=) 50 Percent (%) Improvement in MADRS Total Score From Baseline to Day 43 Baseline to Day 43 Percentage of responders on depressive symptoms scale, defined as a \>= 50 % improvement in MADRS total score from baseline to Day 43 will be reported.
Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43 Day 43 Percentage of participants with remission of depressive symptoms, defined as a MADRS total score \<=10 at Day 43 will be reported.
Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score Baseline to Day 43 Change from baseline to Day 43 in the PHQ-9 total score will be reported.
Change From Baseline Over Time in DARS Total score. For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31 Change from baseline over time in DARS total score will be reported.
Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1). For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31 Change from baseline over time in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) will be reported.
Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 Day 43 Percentage of participants with a score \< 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 will be reported.
Related Research Topics
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Trial Locations
- Locations (83)
Bugat Pal Korhaz
🇭🇺Gyongyos, Hungary
UAB Huntsville Regional Medical Campus
🇺🇸Huntsville, Alabama, United States
IMA Clinical Research PC
🇺🇸Phoenix, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Advanced Research Center Inc
🇺🇸Anaheim, California, United States
CI Trials
🇺🇸Bellflower, California, United States
Viking Clinical Research Ltd
🇺🇸Temecula, California, United States
Behavioral Research Specialists LLC
🇺🇸Glendale, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
ATP Clinical Research
🇺🇸Orange, California, United States
Lumos Clinical Research Center LLC
🇺🇸San Jose, California, United States
Sunwise Clinical Research
🇺🇸Walnut Creek, California, United States
MCB Clinical Research Centers LLC
🇺🇸Colorado Springs, Colorado, United States
Humanity Clinical Research Corp
🇺🇸Aventura, Florida, United States
Elligo Independent Research Sites Mindful Behavioral Health
🇺🇸Boca Raton, Florida, United States
Gulfcoast Medical Research Center
🇺🇸Fort Myers, Florida, United States
New Life Medical Research Center, Inc.
🇺🇸Hialeah, Florida, United States
Medquest Translational Sciences
🇺🇸Miami Lakes, Florida, United States
LCC Medical Research Institute Inc
🇺🇸Miami, Florida, United States
Floridian Clinical Research LLC
🇺🇸Miami, Florida, United States
Best Choice Medical and Research Service
🇺🇸Pembroke Pines, Florida, United States
K2 Medical Research
🇺🇸Tampa, Florida, United States
Neuroscience Research Institute
🇺🇸West Palm Beach, Florida, United States
Accelerated Clinical Trials LLC
🇺🇸Peachtree Corners, Georgia, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Integrative Clinical Trials LLC
🇺🇸Brooklyn, New York, United States
Fieve Clinical Research Inc
🇺🇸New York, New York, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Patient Priority Clinical Sites LLC
🇺🇸Cincinnati, Ohio, United States
OSU Department of Psychiatry and Behavioral Health
🇺🇸Columbus, Ohio, United States
Conrad Clinical Research
🇺🇸Edmond, Oklahoma, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
UTHealth Houston Center for Interventional Psychiatry
🇺🇸Houston, Texas, United States
Brain Health Consultants
🇺🇸Houston, Texas, United States
Red Oak Psychiatry Associates
🇺🇸Houston, Texas, United States
Perceptive Pharma Research
🇺🇸Richmond, Texas, United States
Revival Research Institute LLC
🇺🇸Sherman, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Anima
🇧🇪Alken, Belgium
Chu Tivoli
🇧🇪La Louvière, Belgium
Centre Hospitalier Specialise Notre Dame Des Anges Asbl
🇧🇪Liege, Belgium
Meclinas
🇧🇪Mechelen, Belgium
Eszak Budai Szent Janos Centrumkorhaz
🇭🇺Budapest, Hungary
Universidade Federal do Ceara Hospital Universitario Walter Cantidio
🇧🇷Fortaleza, Brazil
Centro Integrado Facili
🇧🇷Sao Bernardo do Campo, Brazil
BR Trials
🇧🇷Sao Paulo, Brazil
Mental Health Center Prof. Dr. Ivan Temkov
🇧🇬Bourgas, Bulgaria
Medical Center Mentalcare OOD
🇧🇬Plovdiv, Bulgaria
MHC - Sofia, EOOD
🇧🇬Sofia, Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOOD
🇧🇬Sofia, Bulgaria
Terveystalo Ruoholahti
🇫🇮Helsinki, Finland
Savon Psykiatripalvelu
🇫🇮Kuopio, Finland
Northern Clinical Trial Coordinators
🇫🇮Oulu, Finland
Oulu Mentalcare Oy
🇫🇮Oulu, Finland
Mehilainen Finlayson
🇫🇮Tampere, Finland
Clinical Research Services Turku - CRST
🇫🇮Turku, Finland
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Processus Kft
🇭🇺Budapest, Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
🇭🇺Gyor, Hungary
Dr Mathe es Tarsa Bt
🇭🇺Kalocsa, Hungary
Centrum Zdrowia Alcea
🇵🇱Gdansk, Poland
Centrum Badan Klinicznych PI House sp z o o
🇵🇱Gdansk, Poland
Osrodek Badan Klinicznych CLINSANTE S C
🇵🇱Torun, Poland
Pte Aok Pszichiatriai Klinika
🇭🇺Pecs, Hungary
PsychoTech Kft
🇭🇺Pecs, Hungary
Tolna Varmegyei Balassa Janos Korhaz
🇭🇺Szekszard, Hungary
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
🇵🇱Bydgoszcz, Poland
Ginemedica Sp. z o.o.
🇵🇱Wroclaw, Poland
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Institucion Hosp Hestia Palau
🇪🇸Barcelona, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Centro Salud Mental La Corredoria
🇪🇸Oviedo, Spain
Corporacio Sanitari Parc Tauli
🇪🇸Sabadell, Spain
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
Hosp. Alvaro Cunqueiro
🇪🇸Vigo, Spain
Hosp. Prov. de Zamora
🇪🇸Zamora, Spain
Affecta Pskyiatrimottagning
🇸🇪Halmstad, Sweden
Linkoping University Hospital
🇸🇪Linkoping, Sweden
ProbarE i Lund AB
🇸🇪Lund, Sweden
ProbarE i Stockholm AB
🇸🇪Stockholm, Sweden
Studieenheten Akademiskt Specialistcentrum Stockholm
🇸🇪Stockholm, Sweden