A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Particip… (NCT06635135) | Clinical Trial Compass
TerminatedPhase 3
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
Stopped: Early study termination due to insufficient efficacy.
United States, Argentina, Belgium47 participantsStarted 2024-09-19
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 suic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it completed — do you know why it was stopped, and does that affect whether aticaprant is still being studied or considered as a future treatment option for me?
2Since this was a Phase 3 trial combining aticaprant with an existing antidepressant, what does that mean about how much was already known about its safety at the time it was running, and are there any safety signals from the data that was collected that I should be aware of?
3This trial specifically focused on people with major depression who also experience a loss of interest and pleasure — called anhedonia — so how would you assess whether that's a significant part of what I'm experiencing, and does it change my treatment options?
4Because this trial was measuring how long it took for depression symptoms to come back during a maintenance phase, does that suggest my doctor and I should be thinking differently about long-term relapse prevention as part of my overall treatment plan?
5Since this study has been terminated and I can't enroll, what currently available treatments or active trials would you recommend we look at that address both depression and anhedonia together?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse
Timeframe: From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])