Evaluation of Safety, Tolerability, and Feasibility of Aticaprant as Add-On Treatment for Adults with Schizophrenia

What this Trial Is About

Researchers are evaluating the safety, tolerability, and feasibility of aticaprant as an additional treatment for adults with schizophrenia. This phase 1b study aims to see how well participants with schizophrenia can enroll and complete the study assessments while comparing aticaprant to a placebo. The study focuses on participants who are clinically stable and already receiving outpatient treatment for schizophrenia. Participants are randomly assigned to receive either aticaprant or a placebo during the double-blind treatment phase. The study involves monitoring participants over several weeks, with safety and tolerability assessments including adverse events, vital signs, ECGs, laboratory tests, body weight and BMI changes, suicidality assessments, and extrapyramidal symptom evaluations. The study is designed to last up to 126 days for most outcomes, with some measurements taken up to 84 days. Throughout the study, participants will undergo various assessments to evaluate safety and tolerability, including the Columbia Suicide Severity Rating Scale and the Modified Simpson-Angus Scale for extrapyramidal symptoms. Blood samples will confirm medication adherence, and the study will track completion rates of assessments and overall study participation. This detailed monitoring helps researchers understand how participants tolerate aticaprant as an add-on therapy in schizophrenia treatment.

A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia