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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05518149
Registration number
NCT05518149
Ethics application status
Date submitted
25/08/2022
Date registered
26/08/2022
Date last updated
22/05/2024
Titles & IDs
Public title
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
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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)
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Secondary ID [1]
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2022-000430-42
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Secondary ID [2]
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CR109218
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Universal Trial Number (UTN)
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Trial acronym
VENTURA-LT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events (AEs)
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Assessment method [1]
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
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Timepoint [1]
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Up to Week 54
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Primary outcome [2]
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Number of Participants with Adverse Events of Special Interest (AESI)
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Assessment method [2]
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AEs considered to be of special interest are as Pruritus and Diarrhea.
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Timepoint [2]
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Up to Week 54
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Primary outcome [3]
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Number of Participants with Change from Baseline in Vital Signs Abnormalities
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Assessment method [3]
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Vital signs include body weight, temperature, pulse/heart rate, respiratory rate, pulse oximetry and blood pressure (systolic and diastolic) values.
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Timepoint [3]
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Up to Week 54
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Primary outcome [4]
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Number of Participants with Abnormal Body Weight
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Assessment method [4]
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Participants will be weighed at approximately the same time of day on the same scale, wearing lightweight clothing without shoes; they will be instructed to empty their bladders before being weighed.
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Timepoint [4]
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Up to Week 54
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Primary outcome [5]
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Number of Participants with Abnormal Body Mass Index (BMI)
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Assessment method [5]
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A BMI between 18.5 and 25 kilogram per meter square (kg/m^2) indicates a normal weight.
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Timepoint [5]
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Up to Week 54
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Primary outcome [6]
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Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [6]
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C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. The maximum score assigned for each participant will also be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity.
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Timepoint [6]
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Up to Week 54
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Primary outcome [7]
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Number of Participants with Abnormalities in Clinical Laboratory parameters
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Assessment method [7]
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Number of participants with abnormalities in clinical laboratory parameters will be reported.
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Timepoint [7]
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Up to Week 54
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Primary outcome [8]
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Number of Participants with Abnormalities in Electrocardiogram (ECG)
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Assessment method [8]
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Number of participants with abnormalities in ECG will be reported.
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Timepoint [8]
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Up to Week 54
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Primary outcome [9]
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Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
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Assessment method [9]
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Withdrawal symptoms are assessed using the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
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Timepoint [9]
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Up to Week 54
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Primary outcome [10]
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Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
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Assessment method [10]
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The ASEX is a participant-reported five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. Total score ranges from 5 to 30, with the higher scores indicating more sexual dysfunction.
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Timepoint [10]
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Up to Week 54
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Secondary outcome [1]
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Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time
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Assessment method [1]
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Change from baseline in MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
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Timepoint [1]
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Baseline up to Week 54
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Secondary outcome [2]
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Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time
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Assessment method [2]
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Change from baseline in PHQ-9 total score over time will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD) criteria and used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
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Timepoint [2]
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Baseline up to Week 54
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Secondary outcome [3]
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Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time
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Assessment method [3]
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Change from baseline in DARS total score over time will be reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD, and particularly to increase scale generalizability while maintaining specificity. Respondents provide their own examples of rewarding experiences across the domains of hobbies, social activities, food/drink, and sensory experience. Participants answer a set of standardized questions about desire, motivation, effort and consummatory pleasure with a recall period of "right now" for the examples provided. The instrument is scored as a total sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia).
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Timepoint [3]
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Baseline up to Week 54
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Secondary outcome [4]
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Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time
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Assessment method [4]
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Change from baseline in the CGI-S total score over time will be reported. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
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Timepoint [4]
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Baseline up to Week 54
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Secondary outcome [5]
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Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time
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Assessment method [5]
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Percentage of participants with >=50% reduction from baseline in the MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
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Timepoint [5]
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Week 54
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Secondary outcome [6]
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Percentage of Participants with Remission of Depressive Symptoms Over Time
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Assessment method [6]
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Percentage of participants with remission of depressive symptoms over time, defined as a MADRS total score less than or equal to (<=) 10 will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
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Timepoint [6]
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Week 54
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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
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Minimum age
18
Years
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Maximum age
74
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/10/2025
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Actual
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Sample size
Target
840
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peninsula Therapeutic & Research Group - Frankston
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Recruitment hospital [2]
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Albert Road Clinic - Melbourne
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Recruitment postcode(s) [1]
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3199 - Frankston
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Louisiana
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Massachusetts
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Belgium
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Alken
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Belgium
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Sint Niklaas
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Fortaleza
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Porto Alegre
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Rio de Janeiro
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Sao Bernardo
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Sao Paulo
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Bulgaria
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Cherven Bryag
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Plovdiv
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Ruse
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Sofia
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Varna
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Bulgaria
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Veliko Tarnovo
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China
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Beijing
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Czechia
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Brno
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Kutna Hora
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Plzen
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Prague 5
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Douai
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France
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Nantes
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Hungary
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Budapest
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Pecs
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Lecce
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Italy
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Milano
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Italy
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Siena
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Korea, Republic of
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Gyeonggi-do
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Seoul
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Poland
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Bialystok
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Bydgoszcz
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Gdansk
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Lodz
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Poznan
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Suchy Las
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Torun
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Portugal
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Lisboa
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Slovakia
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Banska Bystrica
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Slovakia
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Bojnice
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Slovakia
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Koshice
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Slovakia
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Liptovsky Mikulas
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Slovakia
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Rimavska Sobota
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Slovakia
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Vranov nad Toplou
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South Africa
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Cape Town
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South Africa
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Pretoria
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South Africa
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Strand
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sabadell
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Sweden
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Goteborg
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Sweden
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Lund
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Sweden
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Stockholm
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05518149
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical trial
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Janssen Research & Development, LLC
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Contact person for public queries
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Study Contact
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844-434-4210
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05518149
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