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
- Conditions
- Depressive Disorder, MajorAnhedonia
- Interventions
- Other: Placebo
- Registration Number
- NCT06635135
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 660
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aticaprant Aticaprant - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase) Time from randomization into the DB treatment maintenance phase to the first documentation of a depression relapse event will be reported.
- Secondary Outcome Measures
Name Time Method Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in the MADRS total score to end of DB treatment maintenance phase will be reported.
Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10 From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Percentage of participants with remission of depressive symptoms defined as MADRS total score \<= 10 will be reported.
Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4) From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Percentage of participants with remission of depressive symptoms defined by Patient Health Questionnaire, 9-item (PHQ-9) total score \<=4 will be reported.
Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time For open-label (OL) treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in DB phase Percentage of participants with response defined as greater than or equal to (\>=) 50% improvement in the MADRS total score over time will be reported.
Percentage of Participants With Response of Depressive Symptoms Based on PHQ-9 Total Score Over Time For OL treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in the DB phase Percentage of participants with response of depressive symptoms based on PHQ-9 total score over time will be reported.
Change from DB Baseline in the Clinical Global Impression - Severity (CGI-S) Depression Scale Score From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in the CGI-S depression scale score will be reported.
Change from DB Baseline in PHQ-9 Total Score From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in PHQ-9 total score will be reported.
Change From DB Baseline in Anhedonia as Assessed by the Dimensional Anhedonia Rating Scale (DARS) Total Score From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in Anhedonia as assessed by the DARS total score will be reported.
Change from DB Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score to End of DB Treatment Phase From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in SHAPS score to end of DB treatment phase will be reported.
Percentage of Participants who Relapse and Have Evidence of Anhedonia Over Time From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Percentage of participants who relapse and have evidence of anhedonia over time will be reported.
Change from DB Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score Over Time From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in the GAD-7 total score over time will be reported.
Change from DB Baseline in SF Measured by CSFQ-14 Total Score and SF Domain Scores Over Time From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in SF measured by CSFQ-14 total score and SF domain scores over time will be reported.
Change in Sexual Function (SF) Measured by Changes in Sexual Functioning Questionnaire - Short-Form (CSFQ-14) Total Score From DB Baseline to End of Week 4 of the DB Treatment Maintenance Phase From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study) Change in SF measured by CSFQ-14 total score from DB baseline to end of week 4 of DB treatment maintenance phase will be reported.
Trial Locations
- Locations (95)
Vitaz
🇧🇪Sint Niklaas, Belgium
CAEP Centro Avancado De Estudos E Pesquisas
🇧🇷Campinas, Brazil
Centro Integrado Facili
🇧🇷Sao Bernardo do Campo, Brazil
Mental Health Center - Rousse
🇧🇬Ruse, Bulgaria
Medical Centre Akademika EOOD
🇧🇬Sofia, Bulgaria
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
🇧🇬Sofia, Bulgaria
Diagnostic Consulting Center Mladost - M Varna
🇧🇬Varna, Bulgaria
Mental Health Center - Vratsa EOOD
🇧🇬Vratsa, Bulgaria
CHRU Besancon Hopital Jean Minjoz
🇫🇷Besancon Cedex, France
Hopital la Colombiere
🇫🇷Montpellier, France
CHU de Nantes hotel Dieu
🇫🇷Nantes Cedex 1, France
CHS du Rouvray
🇫🇷Sotteville les Rouen, France
Hopital Sainte Musse
🇫🇷Toulon, France
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Praxis Dr. med. Kirsten Hahn
🇩🇪Berlin, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
🇩🇪Chemnitz, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt Am Main, Germany
Klinische Forschung Hamburg
🇩🇪Hamburg, Germany
Universitaetsklinikum Muenster
🇩🇪Munster, Germany
Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB
🇩🇪Rosenheim, Germany
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Eginitio Hospital
🇬🇷Athens, Greece
Attikon University General Hospital of Attica
🇬🇷Athens, Greece
University Hospital of Heraklion
🇬🇷Heraklion, Greece
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
G Papanikolaou Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Hospital Aranda de la Parra S A de C V
🇲🇽Leon, Mexico
Ketamine Mexico S de RL de C V
🇲🇽Mexico city, Mexico
Human Science Research Trials S de RL de CV
🇲🇽Mexico, Mexico
cit NEUROPSIQUE
🇲🇽Monterrey, Mexico
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
🇵🇱Bydgoszcz, Poland
NZOZ Euromedica Grudziadz
🇵🇱Grudziadz, Poland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
🇵🇱Leszno, Poland
Centrum Medyczne Luxmed Sp z o o
🇵🇱Lublin, Poland
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
🇵🇱Poznan, Poland
Care Access Warszawa
🇵🇱Warszawa, Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
🇵🇱Warszawa, Poland
MTZ Clinical Research Powered by Pratia
🇵🇱Warszawa, Poland
Centrum Zdrowia Mosty
🇵🇱Wroclaw, Poland
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
🇷🇴Bucuresti, Romania
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
🇷🇴Bucuresti, Romania
Centrul Medical Melchisedec
🇷🇴Craiova, Romania
Spitalul Clinic de Neuropsihiatrie
🇷🇴Craiova, Romania
CMI Dr. Sarpe Marcel-Claudiu
🇷🇴Focsani, Romania
Spitalul De Psihiatrie Elisabeta Doamna Galaţi
🇷🇴Galați, Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
🇷🇴Sibiu, Romania
Hosp. Univ. de Basurto
🇪🇸Bilbao, Spain
Hosp Reina Sofia
🇪🇸Cordoba, Spain
Hosp. Univ. Virgen de Las Nieves
🇪🇸Granada, Spain
Hosp. Univ. La Paz
🇪🇸Madrid, Spain
Hosp Virgen de La Victoria
🇪🇸Malaga, Spain
Hosp. Univ. Son Espases
🇪🇸Palma, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Hosp. El Bierzo
🇪🇸Ponferrada, Spain
Hosp. Royo Villanova
🇪🇸Zaragoza, Spain
Erenkoy Mental Health Hospital
🇹🇷Istanbul, Turkey
Wr Pri Llc
🇺🇸Newport Beach, California, United States
ATP Clinical Research
🇺🇸Orange, California, United States
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
🇵🇱Suchy Las, Poland
Myndful Research
🇺🇸Redlands, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Pharmax Research Clinic Inc
🇺🇸Miami, Florida, United States
Anima
🇧🇪Alken, Belgium
AZ Oudenaarde
🇧🇪Oudenaarde, Belgium
Oberhavel Kliniken GmbH
🇩🇪Hennigsdorf, Germany
GTL Medical and Research Group
🇺🇸Miami, Florida, United States
Harmony Clinical Research Inc
🇺🇸North Miami Beach, Florida, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Wake Research PRI Encino
🇺🇸Encino, California, United States
APG Research LLC
🇺🇸Orlando, Florida, United States
UHC Research
🇺🇸Doral, Florida, United States
International Research Associates, LLC
🇺🇸Miami, 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
Keystone Clinical Studies LLC
🇺🇸Plymouth Meeting, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
InSite Clinical Research LLC
🇺🇸DeSoto, Texas, United States
Earle Research
🇺🇸Friendswood, Texas, United States
Alpine Research Organization
🇺🇸Clinton, Utah, United States
Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych
🇺🇸Saint George, Utah, United States
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion
🇦🇷Cordoba, Argentina
AZ Sint-Lucas
🇧🇪Assebroek, Belgium
UZ Brussel
🇧🇪Brussel, Belgium