Trajectory of efficacy and safety across ulotaront dose levels in schizophrenia: a systematic review and dose-response meta-analysis.

ABSTRACT:

Background

Ulotaront is an experimental antipsychotic for schizophrenia, but its optimal dose is unclear. This study aimed to evaluate dose-response relationships for efficacy and safety in people with schizophrenia.

Methods

A systematic review of four databases (until January 22, 2025; INPLASY202510091) identified randomized clinical trials assessing ulotaront. Outcomes included efficacy, measured by changes in the Positive and Negative Syndrome Scale (PANSS) total score (primary outcome), positive and negative subdomains, and the Clinical Global Impression Scale-Severity, and safety, assessed by all-cause dropout (co-primary outcome, dropout due to adverse event, serious, non-serious, and specific adverse events). We employed one-stage dose-response meta-analysis (random-e

SUBMITTER: Hsu YC 

PROVIDER: S-EPMC12421877 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature