Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00835120
Eligibility 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%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00835120
Study Brief:
Protocol Section:
NCT00835120