A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Part of paid clinical trials in Garden Grove, California.
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT07615426
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Aticaprant — DRUGParticipants will receive aticaprant during the double blind (DB) treatment phase.
- Placebo — DRUGParticipants will receive placebo during the DB treatment phase.
Study Details
The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.
Key Dates
- Start date
- Mar 2, 2026
- Status verified
- Jun 2026
- Primary completion
- Jun 21, 2027
- Completion
- Jun 21, 2027
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: AticaprantParticipants will receive aticaprant during the double blind (DB) treatment phase.
- Placebo Comparator: Arm B: PlaceboParticipants will receive placebo during the DB treatment phase.
Primary Outcome Measure
Screen Pass Rate [ Time Frame: Up to 28 days ]
Central Contacts
- Study Contact844-434-4210
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CNS Network | Garden Grove | California | 92845 | - |
| Synexus Clinical Research US Inc | Atlanta | Georgia | 30328 | - |
| Uptown Research Institute | Chicago | Illinois | 60640 | - |
| Western Michigan University | Kalamazoo | Michigan | 49008 | - |
| Neurobehavioral Research Inc | Cedarhurst | New York | 11516 | - |
| Evolution Research Group | Staten Island | New York | 10314 | - |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | - |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | - |
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