A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

• Status: Completed
• Trial end date: 2019-10-21

Summary

The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.

• Phase: Phase 2

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Treatments: Antipsychotic Agents; Aripiprazole; Brexpiprazole; Lurasidone Hydrochloride; Olanzapine; Paliperidone Palmitate; Quetiapine Fumarate; Risperidone; Ziprasidone