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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolic Syndrome Bipolar Depression Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pioglitazone

Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.

Interventions

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Pioglitazone

An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.

Intervention Type DRUG

Other Intervention Names

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Actos

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No