A Long-Term, Phase 2, Multicenter, Randomized, Open-Label Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia

NCT00845026 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Denovo Biopharma LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	261
Start date	2009-03
Completion	2010-12

Conditions

• Schizophrenia

Interventions

• LY2140023
• aripiprazole
• olanzapine
• risperidone

Primary outcomes

• Time to Discontinuation Due to Adverse Event (AE) — Baseline through 24 weeks

Countries

United States, Germany, Mexico, Russia