A Long-Term, Open-Label, Study on Schizophrenia

Status Terminated

Clinical Trial Summary

The primary purpose of the study is to help answer the following research questions:

How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period.

Whether LY 2140023 can help patients with Schizophrenia.

Clinical Trial Description

The study includes 2 treatment periods. Study Period I will begin at patient randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for patients randomized to treatment with LY2140023, and will begin after the patient has completed the second year of treatment. Patients who qualify for enrollment will be randomized in a 3:1 ratio (LY2140023 versus standard of care, respectively) into 2 treatment groups: flexible, twice-daily dose of LY2140023 or standard-of-care (olanzapine, risperidone, aripiprazole, or quetiapine). Those assigned to LY2140023 will have the option to continue on LY2140023 after 2 years if deemed appropriate by the investigator. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Schizophrenia

Clinical Trial Details

NCT number	NCT01129674
Study type	Interventional
Source	Eli Lilly and Company
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	June 2010
Completion date	October 2012

View Details

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