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NCT05455684 · ClinicalTrials.gov registry record · Phase 3
A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 513
- Enrollment target
NCT05455684: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT05455684 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 513 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05455684, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 513 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Primary Outcome
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores fr
Interventions
- OTHER Placebo
- DRUG Aticaprant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 513 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2024-09-18 |
| Phase | Phase 3 |
What the finished NCT05455684 record still lists
NCT05455684 is an interventional study that assigns participants to a tested intervention. The registered 513 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05455684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05455684 about?
NCT05455684 is a clinical study titled "A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy". The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+) who have had an inadequate respons...
What is the current status of trial NCT05455684?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 513 participants. The study started on 2022-06-22. Estimated completion is 2024-09-18.
What interventions are being tested in trial NCT05455684?
The interventions under investigation include: Placebo (OTHER), Aticaprant (DRUG).
Who is sponsoring clinical trial NCT05455684?
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 NCT05455684's enrollment target sits among peer trials
513 727th of 2000 higher than 1,273 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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