Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborators:
National Alliance for Research on Schizophrenia and Depression Takeda Pharmaceuticals North America, Inc.