NCT00194064

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Olanzapine

Timeline

• Start date: 2002-07-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-09-19
• Last updated: 2016-10-04

Locations

1 site across 1 country: United States