NCT00618748

Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed

Safety and Efficacy of Olanzapine (LY170053) in the Long-term Treatment for Patients With Bipolar I Disorder, Depressed

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

Detailed description

This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Olanzapine	5-20 mg/day, oral, daily

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-02-20
• Last updated: 2011-07-27
• Results posted: 2011-06-27

Locations

10 sites across 1 country: Japan