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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
Date last updated
24/10/2024

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).
Trial website
https://clinicaltrials.gov/study/NCT05518149
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05518149