drugset / Trial / NCT03557931
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
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2018-07-13
- Primary completion
- 2019-10-21
- Completion
- 2019-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASP4345 | Small molecule | 50 mg | Oral |
| Subject | ASP4345 | Small molecule | 150 mg | Oral |
| Background | Aripiprazole | Other / unclassified | — | Oral |
| Background | Brexpiprazole | Small molecule | — | Oral |
| Background | Lurasidone | Small molecule | — | Oral |
| Background | Olanzapine | Small molecule | — | Oral |
| Background | Paliperidone | Unknown | — | Oral |
| Background | Quetiapine | Small molecule | — | Oral |
| Background | Risperidone | Other / unclassified | — | Oral |
| Background | Ziprasidone | Small molecule | — | Oral |