Clinical trial NCT06514742: 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
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
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: 2024-07-23
Enrollment: 101
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 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).


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 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

Primary outcomes:
measure: Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Day 43
Secondary outcomes:
measure: Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score
timeFrame: Baseline to Day 43
measure: Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score
timeFrame: Baseline to Day 43
measure: Change From Baseline Over Time in MADRS Total Score
timeFrame: 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
measure: 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
timeFrame: Baseline to Day 43
measure: Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43
timeFrame: Day 43
measure: Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
timeFrame: Baseline to Day 43
measure: Change From Baseline Over Time in DARS Total score.
timeFrame: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
measure: Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1).
timeFrame: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
measure: Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43
timeFrame: Day 43
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: UAB Huntsville Regional Medical Campus
state: Alabama
city: Phoenix
country: United States
facility: IMA Clinical Research PC
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center Inc
state: California
city: Bellflower
country: United States
facility: CI Trials
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists LLC
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Orange
country: United States
facility: ATP Clinical Research
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center LLC
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Ltd
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers LLC
state: Colorado
city: Aventura
country: United States
facility: Humanity Clinical Research Corp
state: Florida
city: Boca Raton
country: United States
facility: Elligo Independent Research Sites Mindful Behavioral Health
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Medical Research Center
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Medquest Translational Sciences
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute Inc
state: Florida
city: Miami
country: United States
facility: Floridian Clinical Research LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Best Choice Medical and Research Service
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Neuroscience Research Institute
state: Florida
city: Peachtree Corners
country: United States
facility: Accelerated Clinical Trials LLC
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: New York
country: United States
facility: Fieve Clinical Research Inc
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites LLC
state: Ohio
city: Columbus
country: United States
facility: OSU Department of Psychiatry and Behavioral Health
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Houston
country: United States
facility: UTHealth Houston Center for Interventional Psychiatry
state: Texas
city: Houston
country: United States
facility: Brain Health Consultants
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: Richmond
country: United States
facility: Perceptive Pharma Research
state: Texas
city: Sherman
country: United States
facility: Revival Research Institute LLC
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Alken
country: Belgium
facility: Anima
city: La Louvière
country: Belgium
facility: Chu Tivoli
city: Liege
country: Belgium
facility: Centre Hospitalier Specialise Notre Dame Des Anges Asbl
city: Mechelen
country: Belgium
facility: Meclinas
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceara Hospital Universitario Walter Cantidio
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Integrado Facili
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Bourgas
country: Bulgaria
facility: Mental Health Center Prof. Dr. Ivan Temkov
city: Plovdiv
country: Bulgaria
facility: Medical Center Mentalcare OOD
city: Sofia
country: Bulgaria
facility: MHC - Sofia, EOOD
city: Sofia
country: Bulgaria
facility: Centre for Mental Health Prof.N.Shipkovenski EOOD
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu
city: Oulu
country: Finland
facility: Northern Clinical Trial Coordinators
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy
city: Tampere
country: Finland
facility: Mehilainen Finlayson
city: Turku
country: Finland
facility: Clinical Research Services Turku - CRST
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Eszak Budai Szent Janos Centrumkorhaz
city: Budapest
country: Hungary
facility: Processus Kft
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Gyor
country: Hungary
facility: Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
city: Kalocsa
country: Hungary
facility: Dr Mathe es Tarsa Bt
city: Pecs
country: Hungary
facility: Pte Aok Pszichiatriai Klinika
city: Pecs
country: Hungary
facility: PsychoTech Kft
city: Szekszard
country: Hungary
facility: Tolna Varmegyei Balassa Janos Korhaz
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
city: Gdansk
country: Poland
facility: Centrum Zdrowia Alcea
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI House sp z o o
city: Torun
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C
city: Wroclaw
country: Poland
facility: Ginemedica Sp. z o.o.
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Institucion Hosp Hestia Palau
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Oviedo
country: Spain
facility: Centro Salud Mental La Corredoria
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Zamora
country: Spain
facility: Hosp. Prov. de Zamora
city: Halmstad
country: Sweden
facility: Affecta Pskyiatrimottagning
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum Stockholm
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: