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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

Bipolar Disorder Clinical Trial

Official title:
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania

Clinical Trial Summary

Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.

Clinical Trial Description

n/a

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00194064
Study type Interventional
Source University Hospitals Cleveland Medical Center
Contact
Status Terminated
Phase Phase 3
Start date July 2002
Completion date February 2006
View Details
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