Schizophrenia Clinical Trials

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A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 1b Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview \[MINI\] for psychotic disorders

• The participant must be on a stable dose of only one atypical antipyschotic medication

• Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening

• At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit

• If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase

Locations
United States
California
CNS Network
RECRUITING
Garden Grove
Georgia
Synexus Clinical Research US Inc
RECRUITING
Atlanta
Illinois
Uptown Research Institute
RECRUITING
Chicago
Michigan
Western Michigan University
RECRUITING
Kalamazoo
New York
Neurobehavioral Research Inc
RECRUITING
Cedarhurst
Evolution Research Group
RECRUITING
Staten Island
Texas
Community Clinical Research, Inc.
RECRUITING
Austin
Pillar Clinical Research, LLC
RECRUITING
Richardson
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2027-06-21
Participants
Target number of participants: 64
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov