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 — DRUG
    Participants will receive aticaprant during the double blind (DB) treatment phase.
  • Placebo — DRUG
    Participants 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: Aticaprant
    Participants will receive aticaprant during the double blind (DB) treatment phase.
  • Placebo Comparator: Arm B: Placebo
    Participants will receive placebo during the DB treatment phase.

Primary Outcome Measure

Screen Pass Rate [ Time Frame: Up to 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
CNS NetworkGarden GroveCalifornia92845-
Synexus Clinical Research US IncAtlantaGeorgia30328-
Uptown Research InstituteChicagoIllinois60640-
Western Michigan UniversityKalamazooMichigan49008-
Neurobehavioral Research IncCedarhurstNew York11516-
Evolution Research GroupStaten IslandNew York10314-
Community Clinical Research, Inc.AustinTexas78754-
Pillar Clinical Research, LLCRichardsonTexas75080-

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