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
Purpose
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.
Conditions
- Depressive Disorder, Major
- Anhedonia
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Aticaprant |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC
