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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: National Alliance for Research on Schizophrenia and Depression; Takeda Pharmaceuticals North America, Inc.
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Be male or female between the ages of 18 and 70

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of bipolar disorder (type I, II, or NOS)

• Currently depressed as confirmed by the MINI-Plus at the screening visit

• Currently receiving treatment with an anti-manic drug

• Meets criteria for metabolic syndrome or insulin resistance

Exclusion Criteria:

• Pregnancy or breast feeding

• Unstable or inadequately treated medical illness as judged by the investigator

• Severe personality disorder

• Serious suicidal risk

• Known history of intolerance or hypersensitivity to pioglitazone

• Treatment with pioglitazone in the 3 months prior to randomization

• Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry

• Currently taking an antidiabetic/glucose-lowering agent.

• Diagnosed with dementia

• Acute Mania as defined by a Young Mania Rating Scale (YMRS) score > 15

• Diagnosed with heart failure

• Transaminase elevation >2.5 times the upper limit of normal

• Presence of renal impairment (eg. creatinine > 1.5)

• Fasting blood glucose >150 mg/dL

• Hb A1c > 7.5%