NCT01526148

Gao Bipolar Spectrum Lithium/Quetiapine Study

Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lithium	Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
DRUG	Quetiapine	Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-02-03
• Last updated: 2017-08-16
• Results posted: 2015-10-30

Locations

1 site across 1 country: United States