Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
| Status: | Completed |
|---|---|
| Conditions: | Depression, Psychiatric, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/23/2013 |
| Start Date: | March 2009 |
| End Date: | October 2013 |
| Contact: | Carla Conroy, BA |
| Email: | carla.conroy@uhhospitals.org |
| Phone: | 216-844-2869 |
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.
Inclusion Criteria:
- Be male or female between the ages of 18 and 70
- 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%
We found this trial at
1
site
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
Click here to add this to my saved trials
