Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia.

ABSTRACT: Despite significant patient burden, there are no approved pharmacotherapies to treat symptoms of cognitive impairment associated with schizophrenia (CIAS). This double-blind, placebo-controlled, parallel-group Phase II trial assessed the efficacy and safety of pharmacological augmentation of at-home computerized cognitive training (CCT) with iclepertin (BI 425809, a glycine transporter-1 inhibitor). Participants with schizophrenia (aged 18-50 years) on stable antipsychotic therapy, who were compliant with CCT during the run-in period, were enrolled. Patients were randomized (1:1) to once daily iclepertin 10 mg or placebo for 12 weeks, and all patients completed adjunctive CCT. At Week 12, the change from baseline in neurocognitive composite T-score of the MATRICS Consensus Cognitive Batter

SUBMITTER: Harvey PD 

PROVIDER: S-EPMC11699300 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature