Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
64
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility, safety, and tolerability of aticaprant as an additional treatment in people with schizophrenia. This randomized, double-blind, placebo-controlled Phase 1b study aims to enroll clinically stable participants receiving outpatient treatment for schizophrenia, comparing aticaprant to placebo to understand how well participants can complete study assessments and tolerate the treatment. Participants will be randomly assigned to receive either aticaprant or a placebo during the double-blind treatment phase. Each participant will continue their stable dose of one atypical antipsychotic medication throughout the study. The study will monitor safety and tolerability by tracking adverse events, vital signs, ECG results, laboratory parameters, body weight, and BMI changes. During the study, participants will undergo multiple assessments including suicidality evaluations using the Columbia Suicide Severity Rating Scale and extrapyramidal symptom assessments with the Modified Simpson-Angus Scale. Completion rates for study assessments and overall study completion will also be measured. The study period includes up to 126 days of observation to collect these safety, tolerability, and feasibility outcomes.
CONDITIONS
Brief Title
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview for psychotic disorders
- On a stable dose of only one atypical antipsychotic medication
- Receiving outpatient treatment for schizophrenia from a psychiatric provider at screening
- Presence of permitted background antipsychotic medication confirmed by blood samples at screening
- No dose changes to antidepressant or anxiolytic medications within 8 weeks prior to screening or during the double blind treatment phase
You will not qualify if you...
- Diagnosis of intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified, substance-induced psychotic disorder, bipolar disorder, or major depressive disorder
- History of moderate-to-severe substance use disorder including alcohol use disorder within 6 months before screening, except nicotine or caffeine
- Current cannabis use exceeding 3 to 5 times in the past 30 days
- History in past 6 months of peptic ulcer, lifetime history of upper gastrointestinal bleeding, untreated helicobacter pylori infection, or diagnosis of zollinger-ellison syndrome
- Current homicidal ideation or intent based on clinical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks
Participants receive aticaprant or placebo as adjunctive treatment for schizophrenia during the double-blind treatment phase.
Multiple visits during the treatment phase
Trial Site Locations
Total: 8 locations
1
CNS Network
Garden Grove, California, United States, 92845
Actively Recruiting
2
Synexus Clinical Research US Inc
Atlanta, Georgia, United States, 30328
Actively Recruiting
3
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
4
Western Michigan University
Kalamazoo, Michigan, United States, 49008
Actively Recruiting
5
Neurobehavioral Research Inc
Cedarhurst, New York, United States, 11516
Actively Recruiting
6
Evolution Research Group
Staten Island, New York, United States, 10314
Actively Recruiting
7
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
Actively Recruiting
8
Pillar Clinical Research, LLC
Richardson, Texas, United States, 75080
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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