A Study 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 and Long-term Extension Treatment With Aticaprant
NCT Number: NCT06514742
Acronym: VENTURA-7
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Depressive Disorder, Major|Anhedonia
Interventions: DRUG: Aticaprant|OTHER: Placebo
Sponsor: Janssen Research & Development, LLC
Sex: ALL
Age: ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2026-07-15
Locations: IMA Clinical Research PC, Phoenix, Arizona, 85012, United States|CI Trials, Bellflower, California, 90706, United States|Behavioral Research Specialists LLC, Glendale, California, 91206, United States|ATP Clinical Research, Orange, California, 92868, United States|Viking Clinical Research Ltd, Temecula, California, 92591, United States|Gulfcoast Medical Research Center, Fort Myers, Florida, 33912, United States|Accelerated Clinical Trials LLC, Peachtree Corners, Georgia, 30071, United States|Integrative Clinical Trials LLC, Brooklyn, New York, 11229, United States|Patient Priority Clinical Sites LLC, Cincinnati, Ohio, 45215, United States|Brain Health Consultants, Houston, Texas, 77046, United States|Red Oak Psychiatry Associates, Houston, Texas, 77090, United States|Revival Research Institute LLC, Sherman, Texas, 75092, United States

Summary:
The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

Primary Outcome Measures: Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, Change from baseline to Day 43 in MADRS total score will be reported., Baseline to Day 43
Secondary Outcome Measures: Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score, Change from baseline to Day 43 in DARS total score will be reported., Baseline to Day 43|Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score, Change from baseline to Day 43 in CSFQ-14 total score will be reported., Baseline to Day 43|Change From Baseline Over Time in MADRS Total Score, Change from baseline over time in the MADRS total score will be reported., For double-blind (DB) treatment phase: Baseline (Day 1), Up to Day 43; For open-label (OL) treatment phase: Baseline (Day 43), Up to Week 31|Percentage of responders on Depressive Symptoms Scale, Defined as a Greater Than or Equal to (>=) 50 Percent (%) Improvement in MADRS Total Score From Baseline to Day 43, Percentage of responders on depressive symptoms scale, defined as a \>= 50 % improvement in MADRS total score from baseline to Day 43 will be reported., Baseline to Day 43|Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43, Percentage of participants with remission of depressive symptoms, defined as a MADRS total score \<=10 at Day 43 will be reported., Day 43|Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score, Change from baseline to Day 43 in the PHQ-9 total score will be reported., Baseline to Day 43|Change From Baseline Over Time in DARS Total score., Change from baseline over time in DARS total score will be reported., For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31|Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1)., Change from baseline over time in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) will be reported., For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31|Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43, Percentage of participants with a score \< 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 will be reported., Day 43