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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05455684




Registration number
NCT05455684
Ethics application status
Date submitted
10/07/2022
Date registered
13/07/2022

Titles & IDs
Public title
A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
Scientific title
A Randomized, Double-blind, Multicenter, Parallel-group, 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
Secondary ID [1] 0 0
2022-000439-22
Secondary ID [2] 0 0
CR109217
Universal Trial Number (UTN)
Trial acronym
VENTURA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Anhedonia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aticaprant
Other interventions - Placebo

Experimental: Aticaprant - Participants will receive aticaprant tablets orally once daily for 42 days during double-blind treatment phase in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003).

Placebo comparator: Placebo - Participants will receive matching placebo orally once daily for 42 days during double-blind treatment phase in addition to their current antidepressant (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003).


Treatment: Drugs: Aticaprant
Aticaprant will be administered orally as tablets.

Other interventions: Placebo
Placebo will be administered orally as tablets.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Day 43
Timepoint [1] 0 0
Baseline to Day 43
Secondary outcome [1] 0 0
Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score to Day 43
Timepoint [1] 0 0
Baseline to Day 43
Secondary outcome [2] 0 0
Change from Baseline in MADRS Total Score over Time
Timepoint [2] 0 0
Baseline up to Day 57
Secondary outcome [3] 0 0
Percentage of Responders on Depressive Symptoms Scale from Baseline to Day 43
Timepoint [3] 0 0
Baseline to Day 43
Secondary outcome [4] 0 0
Percentage of Participants with Remission of Depressive Symptoms Defined as a MADRS Total Score <=10 at Day 43
Timepoint [4] 0 0
Day 43
Secondary outcome [5] 0 0
Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score to Day 43
Timepoint [5] 0 0
Baseline to Day 43
Secondary outcome [6] 0 0
Change from Baseline in DARS Total Score Over Time
Timepoint [6] 0 0
Baseline up to Day 57
Secondary outcome [7] 0 0
Change from Baseline in the PHQ-9 Anhedonia-specific Item (PHQ-9, item 1) Over Time
Timepoint [7] 0 0
Baseline up to Day 57
Secondary outcome [8] 0 0
Percentage of Participants with a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43
Timepoint [8] 0 0
Day 43
Secondary outcome [9] 0 0
Change from Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Short Form-Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) Over Time
Timepoint [9] 0 0
Baseline up to Day 57
Secondary outcome [10] 0 0
Change from Baseline over Time in the Work Productivity and Activity Impairment (WPAI:D)
Timepoint [10] 0 0
Baseline up to Day 43

Eligibility
Key inclusion criteria
* Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
* Have a Hamilton Depression Rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments
* 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, based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT). Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression. An inadequate response is defined as less than(<) 50% reduction in depressive symptom severity but with some improvement (>0%) (ie, there may be minimal to moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function), as assessed by the MGH ATRQ
* Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine at a stable dose for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression
* Participant's current major depressive episode, and antidepressant treatment response in the current depressive episode, must all be confirmed by the site independent qualification assessment
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI (that is, the one presumed to be continued in the treatment phase) 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 had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation device
* Has current, or a history (past 6 months), of seizures
* Has a current 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 Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 or Item 5, 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 baseline should be excluded
* Has one or more of the following diagnoses: a) A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia; b) A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c) A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
538
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peninsula Therapeutic & Research Group - Frankston
Recruitment hospital [2] 0 0
Albert Road Clinic - Melbourne
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad Autonoma Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autonoma de Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad de Mendoza
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Argentina
State/province [21] 0 0
La Plata
Country [22] 0 0
Argentina
State/province [22] 0 0
Rosario
Country [23] 0 0
Belgium
State/province [23] 0 0
Alken
Country [24] 0 0
Belgium
State/province [24] 0 0
Bruxelles
Country [25] 0 0
Belgium
State/province [25] 0 0
Duffel
Country [26] 0 0
Belgium
State/province [26] 0 0
Sint Niklaas
Country [27] 0 0
Brazil
State/province [27] 0 0
Fortaleza
Country [28] 0 0
Brazil
State/province [28] 0 0
Goiania
Country [29] 0 0
Brazil
State/province [29] 0 0
Porto Alegre
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio de Janeiro
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Jose do Rio Preto
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Paulo
Country [33] 0 0
Brazil
State/province [33] 0 0
São Bernardo do Campo
Country [34] 0 0
Brazil
State/province [34] 0 0
São Paulo
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Cherven Bryag
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Plovdiv
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Ruse
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Veliko Tarnovo
Country [40] 0 0
Czechia
State/province [40] 0 0
Klecany
Country [41] 0 0
Czechia
State/province [41] 0 0
Plzen
Country [42] 0 0
Czechia
State/province [42] 0 0
Prague 5
Country [43] 0 0
Czechia
State/province [43] 0 0
Praha 10
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 6
Country [45] 0 0
Czechia
State/province [45] 0 0
Usti nad Labem
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
State/province [47] 0 0
Gyongyos
Country [48] 0 0
Hungary
State/province [48] 0 0
Kalocsa
Country [49] 0 0
Hungary
State/province [49] 0 0
Pecs
Country [50] 0 0
Hungary
State/province [50] 0 0
Szekszárd
Country [51] 0 0
Italy
State/province [51] 0 0
Bergamo
Country [52] 0 0
Italy
State/province [52] 0 0
Catanzaro
Country [53] 0 0
Italy
State/province [53] 0 0
Lecce
Country [54] 0 0
Italy
State/province [54] 0 0
Milano
Country [55] 0 0
Italy
State/province [55] 0 0
Siena
Country [56] 0 0
Poland
State/province [56] 0 0
Belchatow
Country [57] 0 0
Poland
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Bialystok
Country [58] 0 0
Poland
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Gdansk
Country [59] 0 0
Poland
State/province [59] 0 0
Lodz
Country [60] 0 0
Poland
State/province [60] 0 0
Poznan
Country [61] 0 0
Poland
State/province [61] 0 0
Torun
Country [62] 0 0
Portugal
State/province [62] 0 0
Braga
Country [63] 0 0
Portugal
State/province [63] 0 0
Lisboa
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Málaga
Country [67] 0 0
Spain
State/province [67] 0 0
Palma de Mallorca
Country [68] 0 0
Spain
State/province [68] 0 0
Ponferrada
Country [69] 0 0
Spain
State/province [69] 0 0
Sabadell
Country [70] 0 0
Spain
State/province [70] 0 0
Vigo
Country [71] 0 0
Spain
State/province [71] 0 0
Vitoria
Country [72] 0 0
Sweden
State/province [72] 0 0
Goteborg
Country [73] 0 0
Sweden
State/province [73] 0 0
Lund
Country [74] 0 0
Sweden
State/province [74] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05455684