Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 8:12 AM
Study NCT ID:
NCT06635135
Status:
TERMINATED
Last Update Posted:
2025-11-07
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D059445', 'term': 'Anhedonia'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000590915', 'term': 'Aticaprant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Early study termination due to insufficient efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse', 'timeFrame': 'From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase)', 'description': 'Time from randomization into the DB treatment maintenance phase to the first documentation of a depression relapse event will be reported.'}], 'secondaryOutcomes': [{'measure': 'Change in Sexual Function (SF) Measured by Changes in Sexual Functioning Questionnaire - Short-Form (CSFQ-14) Total Score From DB Baseline to End of Week 4 of the DB Treatment Maintenance Phase', 'timeFrame': 'From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study)', 'description': 'Change in SF measured by CSFQ-14 total score from DB baseline to end of week 4 of DB treatment maintenance phase will be reported.'}, {'measure': 'Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in the MADRS total score to end of DB treatment maintenance phase will be reported.'}, {'measure': 'Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Percentage of participants with remission of depressive symptoms defined as MADRS total score \\<= 10 will be reported.'}, {'measure': 'Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4)', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Percentage of participants with remission of depressive symptoms defined by Patient Health Questionnaire, 9-item (PHQ-9) total score \\<=4 will be reported.'}, {'measure': 'Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time', 'timeFrame': 'For open-label (OL) treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in DB phase', 'description': 'Percentage of participants with response defined as greater than or equal to (\\>=) 50% improvement in the MADRS total score over time will be reported.'}, {'measure': 'Percentage of Participants With Response of Depressive Symptoms Based on PHQ-9 Total Score Over Time', 'timeFrame': 'For OL treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in the DB phase', 'description': 'Percentage of participants with response of depressive symptoms based on PHQ-9 total score over time will be reported.'}, {'measure': 'Change from DB Baseline in the Clinical Global Impression - Severity (CGI-S) Depression Scale Score', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in the CGI-S depression scale score will be reported.'}, {'measure': 'Change from DB Baseline in PHQ-9 Total Score', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in PHQ-9 total score will be reported.'}, {'measure': 'Change From DB Baseline in Anhedonia as Assessed by the Dimensional Anhedonia Rating Scale (DARS) Total Score', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in Anhedonia as assessed by the DARS total score will be reported.'}, {'measure': 'Change from DB Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score to End of DB Treatment Phase', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in SHAPS score to end of DB treatment phase will be reported.'}, {'measure': 'Percentage of Participants who Relapse and Have Evidence of Anhedonia Over Time', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Percentage of participants who relapse and have evidence of anhedonia over time will be reported.'}, {'measure': 'Change from DB Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score Over Time', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in the GAD-7 total score over time will be reported.'}, {'measure': 'Change from DB Baseline in SF Measured by CSFQ-14 Total Score and SF Domain Scores Over Time', 'timeFrame': 'From Week 16 (DB baseline) up to 2 years 2 months in the DB phase', 'description': 'Change from DB baseline in SF measured by CSFQ-14 total score and SF domain scores over time will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major', 'Anhedonia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \\[SSRI\\] or serotonin-norepinephrine reuptake inhibitor \\[SNRI\\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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 OL baseline\n* Be medically stable based on clinical laboratory tests performed at screening\n* Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) Axis I Disorders-Clinical Trials version (SCID-CT)\n* Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening\n\nExclusion Criteria:\n\n* Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)\n* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy\n* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening\n* 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\n* Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements"}, 'identificationModule': {'nctId': 'NCT06635135', 'acronym': 'VENTURA-5', 'briefTitle': 'A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia', 'orgStudyIdInfo': {'id': '67953964MDD3005'}, 'secondaryIdInfos': [{'id': '67953964MDD3005', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2024-511057-22-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aticaprant', 'interventionNames': ['Drug: Aticaprant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Aticaprant', 'type': 'DRUG', 'otherNames': ['JNJ-67953964'], 'description': 'Aticaprant will be administered orally.', 'armGroupLabels': ['Aticaprant']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91316', 'city': 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