Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05518149




Registration number
NCT05518149
Ethics application status
Date submitted
25/08/2022
Date registered
26/08/2022

Titles & IDs
Public title
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Scientific title
An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Secondary ID [1] 0 0
2022-000430-42
Secondary ID [2] 0 0
CR109218
Universal Trial Number (UTN)
Trial acronym
VENTURA-LT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

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

Experimental: Aticaprant 10 mg - Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.


Treatment: Drugs: Aticaprant
Aticaprant 10 mg tablet will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to Week 54
Primary outcome [2] 0 0
Number of Participants with Adverse Events of Special Interest (AESI)
Timepoint [2] 0 0
Up to Week 54
Primary outcome [3] 0 0
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Timepoint [3] 0 0
Up to Week 54
Primary outcome [4] 0 0
Number of Participants with Abnormal Body Weight
Timepoint [4] 0 0
Up to Week 54
Primary outcome [5] 0 0
Number of Participants with Abnormal Body Mass Index (BMI)
Timepoint [5] 0 0
Up to Week 54
Primary outcome [6] 0 0
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [6] 0 0
Up to Week 54
Primary outcome [7] 0 0
Number of Participants with Abnormalities in Clinical Laboratory parameters
Timepoint [7] 0 0
Up to Week 54
Primary outcome [8] 0 0
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Timepoint [8] 0 0
Up to Week 54
Primary outcome [9] 0 0
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
Timepoint [9] 0 0
Up to Week 54
Primary outcome [10] 0 0
Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
Timepoint [10] 0 0
Up to Week 54
Secondary outcome [1] 0 0
Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time
Timepoint [1] 0 0
Baseline up to Week 54
Secondary outcome [2] 0 0
Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time
Timepoint [2] 0 0
Baseline up to Week 54
Secondary outcome [3] 0 0
Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time
Timepoint [3] 0 0
Baseline up to Week 54
Secondary outcome [4] 0 0
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time
Timepoint [4] 0 0
Baseline up to Week 54
Secondary outcome [5] 0 0
Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time
Timepoint [5] 0 0
Week 54
Secondary outcome [6] 0 0
Percentage of Participants with Remission of Depressive Symptoms Over Time
Timepoint [6] 0 0
Week 54

Eligibility
Key inclusion criteria
Transferred-entry participants:

-Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study

Direct-entry participants:

* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* 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
* Must be an outpatient at open-label treatment phase 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, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)

Direct-entry and Transferred-entry Participants:

-Participants should not take any prohibited medication or food supplements
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Transferred-entry Participants:

* Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
* Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments

Direct-entry Participants:

* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
22/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
840
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
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Ciudad Autonoma Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma de Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad de Mendoza
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Argentina
State/province [26] 0 0
Córdoba
Country [27] 0 0
Argentina
State/province [27] 0 0
La Plata
Country [28] 0 0
Argentina
State/province [28] 0 0
Rosario
Country [29] 0 0
Argentina
State/province [29] 0 0
San Miguel de Tucuman
Country [30] 0 0
Argentina
State/province [30] 0 0
Santiago del Estero
Country [31] 0 0
Belgium
State/province [31] 0 0
Alken
Country [32] 0 0
Belgium
State/province [32] 0 0
Sint Niklaas
Country [33] 0 0
Brazil
State/province [33] 0 0
Curitiba
Country [34] 0 0
Brazil
State/province [34] 0 0
Fortaleza
Country [35] 0 0
Brazil
State/province [35] 0 0
Goiania
Country [36] 0 0
Brazil
State/province [36] 0 0
Porto Alegre
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro
Country [38] 0 0
Brazil
State/province [38] 0 0
Sao Bernardo
Country [39] 0 0
Brazil
State/province [39] 0 0
Sao Jose do Rio Preto
Country [40] 0 0
Brazil
State/province [40] 0 0
Sao Paulo
Country [41] 0 0
Brazil
State/province [41] 0 0
São Paulo
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Cherven Bryag
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Plovdiv
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Ruse
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Sofia
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Varna
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Veliko Tarnovo
Country [48] 0 0
China
State/province [48] 0 0
Baoding
Country [49] 0 0
China
State/province [49] 0 0
Beijing
Country [50] 0 0
China
State/province [50] 0 0
Chengdu
Country [51] 0 0
China
State/province [51] 0 0
Guangzhou
Country [52] 0 0
China
State/province [52] 0 0
Shanghai
Country [53] 0 0
China
State/province [53] 0 0
Shijiazhuang
Country [54] 0 0
China
State/province [54] 0 0
Tianjin
Country [55] 0 0
China
State/province [55] 0 0
XI An
Country [56] 0 0
Czechia
State/province [56] 0 0
Brno
Country [57] 0 0
Czechia
State/province [57] 0 0
Klecany
Country [58] 0 0
Czechia
State/province [58] 0 0
Kutna Hora
Country [59] 0 0
Czechia
State/province [59] 0 0
Plzen
Country [60] 0 0
Czechia
State/province [60] 0 0
Prague 5
Country [61] 0 0
Czechia
State/province [61] 0 0
Praha 10
Country [62] 0 0
Czechia
State/province [62] 0 0
Praha 6
Country [63] 0 0
Czechia
State/province [63] 0 0
Praha 8
Country [64] 0 0
Czechia
State/province [64] 0 0
Usti nad Labem
Country [65] 0 0
France
State/province [65] 0 0
Douai
Country [66] 0 0
France
State/province [66] 0 0
Nantes
Country [67] 0 0
Hungary
State/province [67] 0 0
Budapest
Country [68] 0 0
Hungary
State/province [68] 0 0
Gyongyos
Country [69] 0 0
Hungary
State/province [69] 0 0
Kalocsa
Country [70] 0 0
Hungary
State/province [70] 0 0
Pecs
Country [71] 0 0
Italy
State/province [71] 0 0
Milano
Country [72] 0 0
Italy
State/province [72] 0 0
Siena
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyeonggi-do
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul
Country [75] 0 0
Poland
State/province [75] 0 0
Bialystok
Country [76] 0 0
Poland
State/province [76] 0 0
Bydgoszcz
Country [77] 0 0
Poland
State/province [77] 0 0
Gdansk
Country [78] 0 0
Poland
State/province [78] 0 0
Katowice
Country [79] 0 0
Poland
State/province [79] 0 0
Lodz
Country [80] 0 0
Poland
State/province [80] 0 0
Poznan
Country [81] 0 0
Poland
State/province [81] 0 0
Suchy Las
Country [82] 0 0
Poland
State/province [82] 0 0
Torun
Country [83] 0 0
Portugal
State/province [83] 0 0
Braga
Country [84] 0 0
Portugal
State/province [84] 0 0
Lisboa
Country [85] 0 0
Slovakia
State/province [85] 0 0
Banska Bystrica
Country [86] 0 0
Slovakia
State/province [86] 0 0
Bojnice
Country [87] 0 0
Slovakia
State/province [87] 0 0
Bratislava
Country [88] 0 0
Slovakia
State/province [88] 0 0
Koshice
Country [89] 0 0
Slovakia
State/province [89] 0 0
Kosice
Country [90] 0 0
Slovakia
State/province [90] 0 0
Liptovsky Mikulas
Country [91] 0 0
Slovakia
State/province [91] 0 0
Rimavska Sobota
Country [92] 0 0
Slovakia
State/province [92] 0 0
Vranov nad Toplou
Country [93] 0 0
South Africa
State/province [93] 0 0
Cape Town
Country [94] 0 0
South Africa
State/province [94] 0 0
Pretoria
Country [95] 0 0
South Africa
State/province [95] 0 0
Strand
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Málaga
Country [99] 0 0
Spain
State/province [99] 0 0
Palma de Mallorca
Country [100] 0 0
Spain
State/province [100] 0 0
Ponferrada
Country [101] 0 0
Spain
State/province [101] 0 0
Sabadell
Country [102] 0 0
Sweden
State/province [102] 0 0
Goteborg
Country [103] 0 0
Sweden
State/province [103] 0 0
Lund
Country [104] 0 0
Sweden
State/province [104] 0 0
Stockholm
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taichung
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taipei City
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taipei
Country [108] 0 0
United Kingdom
State/province [108] 0 0
London
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Southampton

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/NCT05518149