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NCT06635135 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 47
- Enrollment target
NCT06635135: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT06635135 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 47 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06635135, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
Relapse is defined as any of the following: MADRS total score \>=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prev
Interventions
- OTHER Placebo
- DRUG Aticaprant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2024-09-19 |
| Est. Completion | 2025-04-25 |
| Phase | Phase 3 |
Why NCT06635135 stopped before completion
NCT06635135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06635135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06635135 about?
NCT06635135 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06635135?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2024-09-19. Estimated completion is 2025-04-25.
What interventions are being tested in trial NCT06635135?
The interventions under investigation include: Placebo (OTHER), Aticaprant (DRUG).
Who is sponsoring clinical trial NCT06635135?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06635135's enrollment target sits among peer trials
47 1867th of 2000 higher than 133 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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