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

This study is currently recruiting participants.

Verified August 2011 by University Hospital Case Medical Center

First Received on February 2, 2009. Last Updated on August 3, 2011 History of Changes

Sponsor:	University Hospital Case Medical Center
Collaborators:	National Alliance for Research on Schizophrenia and Depression Takeda Pharmaceuticals North America, Inc.
Information provided by:	University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT00835120

Purpose

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.

Condition	Intervention	Phase
Metabolic Syndrome Bipolar Depression Insulin Resistance	Drug: Pioglitazone	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression Diabetes Medicines Metabolic Syndrome

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:

Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
Response rates on the IDS-CR, MADRS and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
Remission rates based on IDS-CR, QIDS-SR, and MADRS scores [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
Change in Clinical Global Impressions-Bipolar Version (CGI-BP) and Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A) scores [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pioglitazone Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes	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. Other Name: Actos

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835120

Contacts

Contact: Sarah Obral, BA

216-844-2869

sarah.obral@UHhospitals.org

Locations

United States, Ohio
University Hospitals Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sarah Obral, B 216-844-2869 sarah.obral@UHhospitals.org
Principal Investigator: David E Kemp, MD

Sponsors and Collaborators

University Hospital Case Medical Center

National Alliance for Research on Schizophrenia and Depression

Takeda Pharmaceuticals North America, Inc.

Investigators

Principal Investigator:

David E Kemp, MD

Univeristy Hospitals Case Medical Center

More Information

No publications provided

Responsible Party:	David E. Kemp, MD, University Hospitals Case Medical Center
ClinicalTrials.gov Identifier:	NCT00835120 History of Changes
Other Study ID Numbers:	07-08-24
Study First Received:	February 2, 2009
Last Updated:	August 3, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Insulin Resistance
Metabolic Syndrome X
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

Behavioral Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012