A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

Registry record from ClinicalTrials.gov (NCT05518149). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: TERMINATED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 871 participants (ACTUAL). Conditions: Depressive Disorder, Major. Interventions: DRUG: Aticaprant. Primary outcome measures: Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI) , From start of open-label treatment (Day 1) up to Week 52; Follow-up Phase: Number of Participants With Adverse Events (AEs) and AEs of Special Interest (AESI) , From Week 52 to Week 54; Change From Baseline in Vital Sign Parameter: Blood Pressure (Systolic and Diastolic Blood Pressure) , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]); Change From Baseline in Vital Sign Parameter: Pulse Rate , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]); Change From Baseline in Vital Sign Parameter: Temperature , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]); Change From Baseline in Vital Sign Parameter: Weight , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]); Change From Baseline in Body Mass Index (BMI) , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54]); OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by Columbia Suicidality Severity Rating Scale (C-SSRS) , Baseline (DB, Day 1) up to Endpoint (OL) (at any time between Week 4 to Week 52) (Up to Week 58 from DB baseline); Follow-up Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by C-SSRS , Baseline (DB, Day 1), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52]) (maximum up to Week 54 from OL baseline and Week 60 from DB baseline); OL Treatment Phase: Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameters: Albumin, Protein, Erythrocyte (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin, Urate , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, Leukocytes , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV) , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in Laboratory Parameter: Squamous Epithelial Cells, Transitional Epithelial Cells, Tubular Epithelial Cells, Urine Erythrocytes, Urine Leukocytes , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, RR Interval, QTcB Interval, QTcF Interval , Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52); OL Treatment Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20) , Endpoint (OL) (at any time between Day 2 to Week 52); Follow-up Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20) , Follow-up (up to 14 days after endpoint (OL) [at any time between Day 2 to Week 52 {maximum up to Week 54}]); OL Treatment Phase: Percentage of Participants With Clinically Relevant Sexual Dysfunction Over Time as Determined by Arizona Sexual Experiences Scale (ASEX) , Endpoint (OL) (at any time between Week 12 to Week 52). 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 reuptak