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
- Conditions
- Depressive Disorder, MajorAnhedonia
- Interventions
- Other: Placebo
- Registration Number
- NCT06635135
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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
- Be medically stable based on clinical laboratory tests performed at screening
- 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)
- 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
- 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)
- Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
- Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aticaprant Aticaprant - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse 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) Time from randomization into the DB treatment maintenance phase to the first documentation of a depression relapse event will be reported.
- Secondary Outcome Measures
Name Time Method Change from DB Baseline in PHQ-9 Total Score From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in PHQ-9 total score will be reported.
Change From DB Baseline in Anhedonia as Assessed by the Dimensional Anhedonia Rating Scale (DARS) Total Score From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in Anhedonia as assessed by the DARS total score will be reported.
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 From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study) 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.
Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in the MADRS total score to end of DB treatment maintenance phase will be reported.
Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10 From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Percentage of participants with remission of depressive symptoms defined as MADRS total score \<= 10 will be reported.
Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4) From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Percentage of participants with remission of depressive symptoms defined by Patient Health Questionnaire, 9-item (PHQ-9) total score \<=4 will be reported.
Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time 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 Percentage of participants with response defined as greater than or equal to (\>=) 50% improvement in the MADRS total score over time will be reported.
Percentage of Participants With Response of Depressive Symptoms Based on PHQ-9 Total Score Over Time 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 Percentage of participants with response of depressive symptoms based on PHQ-9 total score over time will be reported.
Change from DB Baseline in the Clinical Global Impression - Severity (CGI-S) Depression Scale Score From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in the CGI-S depression scale score will be reported.
Change from DB Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score to End of DB Treatment Phase From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in SHAPS score to end of DB treatment phase will be reported.
Percentage of Participants who Relapse and Have Evidence of Anhedonia Over Time From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Percentage of participants who relapse and have evidence of anhedonia over time will be reported.
Change from DB Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score Over Time From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in the GAD-7 total score over time will be reported.
Change from DB Baseline in SF Measured by CSFQ-14 Total Score and SF Domain Scores Over Time From Week 16 (DB baseline) up to 2 years 2 months in the DB phase Change from DB baseline in SF measured by CSFQ-14 total score and SF domain scores over time will be reported.
Trial Locations
- Locations (95)
Wr Pri Llc
🇺🇸Newport Beach, California, United States
ATP Clinical Research
🇺🇸Orange, California, United States
Anima
🇧🇪Alken, Belgium
AZ Oudenaarde
🇧🇪Oudenaarde, Belgium
Oberhavel Kliniken GmbH
🇩🇪Hennigsdorf, Germany
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
🇵🇱Suchy Las, Poland
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Wake Research PRI Encino
🇺🇸Encino, California, United States
Myndful Research
🇺🇸Redlands, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
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