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NCT05550532 · ClinicalTrials.gov registry record · Phase 3
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
A Phase 3 study of Depressive Disorder, Major and Anhedonia, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
- 20
- Study locations
NCT05550532: Completed Phase 3 study of Depressive Disorder, Major and Anhedonia, sponsored by Janssen Research & Development.
NCT05550532 is a Phase 3 study of Depressive Disorder, Major and Anhedonia that has completed, run by Janssen Research & Development. The registered enrollment target is 444 participants, above the 234-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05550532, a Phase 3 study of Depressive Disorder, Major and Anhedonia, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Aticaprant
Study Locations (20)
Florida
- CNS Clinical Research Group - Coral Springs
- Sarkis Clinical Trials - Gainesville
- New Life Medical Research Center, Inc. - Hialeah
- K2 Medical Research - Maitland
- Vital Care Research - Miami
- Global Medical Institutes - Miami
- LCC Medical Research Institute Inc - Miami
- Florida Research Center Inc. - Miami
- Ezy Medical Research - Miami
- Felicidad Medical Research - Miami
California
- Sunwise Clinical Research - Lafayette
- Pacific Neuropsychiatric Specialists - Orange
- Prospective Research Innovations Inc - Rancho Cucamonga
- University of California San Diego Medical Center - San Diego
- CMB Clinical Trials - Santee
- California Neuroscience Research - Sherman Oaks
- Pacific Clinical Research Medical Group - Upland
- Next Level Clinical Trials, LLC - West Covina
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- MCB Clinical Research Centers LLC - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2024-11-13 |
| Phase | Phase 3 |
What the finished NCT05550532 record still lists
NCT05550532 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (90% higher).
The record links to 2 conditions, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05550532 names 20 study sites across 4 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05550532 about?
NCT05550532 is a clinical study titled "A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With 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 NCT05550532?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. The study started on 2022-12-06. Estimated completion is 2024-11-13.
What conditions does trial NCT05550532 study?
This clinical trial studies the following conditions: Depressive Disorder, Major, Anhedonia.
What interventions are being tested in trial NCT05550532?
The interventions under investigation include: Placebo (OTHER), Aticaprant (DRUG).
Who is sponsoring clinical trial NCT05550532?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05550532 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05550532's enrollment target sits among peer trials
444 13th of 52 higher than 40 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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.
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