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
Janssen Research & Development, LLC
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * 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…