Clinical trial NCT06635135: 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
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Depressive Disorder, Major
Anhedonia
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse
timeFrame: 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)
Secondary outcomes:
measure: 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
timeFrame: From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study)
measure: Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4)
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time
timeFrame: 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
measure: Percentage of Participants With Response of Depressive Symptoms Based on PHQ-9 Total Score Over Time
timeFrame: 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
measure: Change from DB Baseline in the Clinical Global Impression - Severity (CGI-S) Depression Scale Score
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Change from DB Baseline in PHQ-9 Total Score
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Change From DB Baseline in Anhedonia as Assessed by the Dimensional Anhedonia Rating Scale (DARS) Total Score
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Change from DB Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score to End of DB Treatment Phase
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Percentage of Participants who Relapse and Have Evidence of Anhedonia Over Time
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Change from DB Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score Over Time
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
measure: Change from DB Baseline in SF Measured by CSFQ-14 Total Score and SF Domain Scores Over Time
timeFrame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Encino
country: United States
facility: Wake Research PRI Encino
state: California
city: Newport Beach
country: United States
facility: Wr Pri Llc
state: California
city: Orange
country: United States
facility: ATP Clinical Research
state: California
city: Redlands
country: United States
facility: Myndful Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Doral
country: United States
facility: UHC Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: GTL Medical and Research Group
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research Inc
state: Florida
city: Orlando
country: United States
facility: APG Research LLC
state: Florida
city: Tampa
country: United States
facility: Interventional Psychiatry of Tampa Bay
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US Inc
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Skokie
country: United States
facility: Psychiatric Medicine Associates LLC
state: Illinois
city: Towson
country: United States
facility: Continental Clinical Solutions
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Albuquerque
country: United States
facility: IMA Clinical Research PC
state: New Mexico
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research LLC
state: New York
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites LLC
state: Ohio
city: Independence
country: United States
facility: Insight Clinical Trials
state: Ohio
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies LLC
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: DeSoto
country: United States
facility: InSite Clinical Research LLC
state: Texas
city: Friendswood
country: United States
facility: Earle Research
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: Saint George
country: United States
facility: Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych
state: Utah
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Cordoba
country: Argentina
facility: Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion
city: Alken
country: Belgium
facility: Anima
city: Assebroek
country: Belgium
facility: AZ Sint-Lucas
city: Brussel
country: Belgium
facility: UZ Brussel
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Campinas
country: Brazil
facility: CAEP Centro Avancado De Estudos E Pesquisas
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Integrado Facili
city: Ruse
country: Bulgaria
facility: Mental Health Center - Rousse
city: Sofia
country: Bulgaria
facility: Medical Centre Akademika EOOD
city: Sofia
country: Bulgaria
facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
city: Varna
country: Bulgaria
facility: Diagnostic Consulting Center Mladost - M Varna
city: Vratsa
country: Bulgaria
facility: Mental Health Center - Vratsa EOOD
city: Besancon Cedex
country: France
facility: CHRU Besancon Hopital Jean Minjoz
city: Montpellier
country: France
facility: Hopital la Colombiere
city: Nantes Cedex 1
country: France
facility: CHU de Nantes hotel Dieu
city: Sotteville les Rouen
country: France
facility: CHS du Rouvray
city: Toulon
country: France
facility: Hopital Sainte Musse
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Praxis Dr. med. Kirsten Hahn
city: Chemnitz
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH
city: Frankfurt Am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH
city: Munster
country: Germany
facility: Universitaetsklinikum Muenster
city: Rosenheim
country: Germany
facility: Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Athens
country: Greece
facility: Eginitio Hospital
city: Athens
country: Greece
facility: Attikon University General Hospital of Attica
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Thessaloniki
country: Greece
facility: G Papanikolaou Hospital of Thessaloniki
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra S A de C V
city: Mexico city
country: Mexico
facility: Ketamine Mexico S de RL de C V
city: Mexico
country: Mexico
facility: Human Science Research Trials S de RL de CV
city: Monterrey
country: Mexico
facility: cit NEUROPSIQUE
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
city: Grudziadz
country: Poland
facility: NZOZ Euromedica Grudziadz
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed Sp z o o
city: Poznan
country: Poland
facility: Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
city: Suchy Las
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
city: Warszawa
country: Poland
facility: Care Access Warszawa
city: Warszawa
country: Poland
facility: Szpital Nowowiejski Osrodek Badan Klinicznych
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Wroclaw
country: Poland
facility: Centrum Zdrowia Mosty
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
city: Bucuresti
country: Romania
facility: Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
city: Craiova
country: Romania
facility: Centrul Medical Melchisedec
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie
city: Focsani
country: Romania
facility: CMI Dr. Sarpe Marcel-Claudiu
city: Galați
country: Romania
facility: Spitalul De Psihiatrie Elisabeta Doamna Galaţi
city: Sibiu
country: Romania
facility: Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Malaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Palma
country: Spain
facility: Hosp. Univ. Son Espases
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Ponferrada
country: Spain
facility: Hosp. El Bierzo
city: Zaragoza
country: Spain
facility: Hosp. Royo Villanova
city: Istanbul
country: Turkey
facility: Erenkoy Mental Health Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: