drugset / Trial / NCT00845026
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
RandomizedParallel-groupSingle-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 20 mg | Oral |
| Subject | LY2140023 | Unknown | 80 mg | Oral |
| Comparator | Olanzapine | Small molecule | 15 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 4 mg | Oral |