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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835120
• Other study ID #: 07-08-24
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2009
• Last updated: October 10, 2014
• Start date: March 2009
• Est. completion date: April 2013

Study information

• Verified date: October 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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%

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	National Alliance for Research on Schizophrenia and Depression, Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score	Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome	Week 0 - Week 8	No
Secondary	Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score	The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome	Week 0 - Week 8	No
Secondary	Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)		Week 0 - Week 8	No
Secondary	Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores		Week 0 - Week 8	No
Secondary	Change in Clinical Global Impressions-Bipolar Version (CGI-BP)	The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.	Week 0 - Week 8	No