A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients

Summary

The primary objective of this study was to assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those on atypical antipsychotic standard-of-care (SOC) treatment. Lack of tolerability was defined as discontinuation due to adverse events (AEs). Patients who completed the active treatment phase were eligible to continue to an optional 28 weeks of treatment extension phase. This extension phase assessed key safety and efficacy measures.

Timeline

Start

2009-03

Primary completion

2010-05

Completion

2010-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry LY2140023 vs Standard-of-Care (SOC); p = 0.184; Log Rank NCT00845026 ↗

Drugs

Indications