NCT00835120

Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.

Conditions

• Metabolic Syndrome
• Bipolar Depression
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Pioglitazone	An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2009-02-03
• Last updated: 2017-01-26
• Results posted: 2014-10-17

Locations

1 site across 1 country: United States