Status:
COMPLETED
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Takeda Pharmaceuticals North America, Inc.
Conditions:
Metabolic Syndrome
Bipolar Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00835120
Start Date
March 1 2009
End Date
April 1 2013
Last Update
January 26 2017
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106