Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

This study is currently recruiting participants.

Verified by University Hospital Case Medical Center, July 2009

First Received: May 1, 2008 Last Updated: July 17, 2009 History of Changes

Sponsored by:	University Hospital Case Medical Center
Information provided by:	University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT00671515

Purpose

The goal of this study is to begin to test whether or not pioglitazone, an FDA approved medication used to treat high blood sugar, may be safe and effective in treating Major Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).

Condition	Intervention	Phase
Depressive Disorder, Major Metabolic Syndrome X	Drug: Pioglitazone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Depression Metabolic Syndrome

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

IDS-CR score change from baseline to study endpoint [ Time Frame: Week 0 - Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Prevalence of metabolic syndrome [ Time Frame: Week 0 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

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 major depressive disorder
Currently depressed as confirmed by the MINI-Plus at the screening visit
Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR) score > 11 at study baseline
Meets criteria for the metabolic syndrome as defined by the NCEP ATP III criteria

Exclusion Criteria:

Pregnancy or breast feeding
Unstable or inadequately treated medical illness as judged by the investigator
Severe personality disorder
Serious suicidal risk as judged by the investigator or having a score > 2 on item 18 of the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) scale
Known history of intolerance or hypersensitivity to pioglitazone
Treatment with pioglitazone in the 3 months prior to randomization
Currently taking an antidiabetic/glucose-lowering agent. Antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
Diagnosed with dementia
Diagnosed with heart failure
Transaminase elevation >2.5 times the upper limit of normal
Presence of renal impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671515

Contacts

Contact: Sarah Obral, BA

216-844-2869

sarah.obral@UHhospitals.org

Locations

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

Sponsors and Collaborators

University Hospital Case Medical Center

Investigators

Principal Investigator:

David E Kemp, MD

University Hospitals Case Medical Center - Mood Disorders Program

More Information

No publications provided

Responsible Party:	University Hospital Case Medical Center - Mood Disorders Program ( David E. Kemp, MD )
Study ID Numbers:	07-07-20
Study First Received:	May 1, 2008
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00671515 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:

Depressive Disorder, Major
Metabolic Syndrome X
pioglitazone

Study placed in the following topic categories:

Metabolic Syndrome X
Depression
Metabolic Diseases
Pioglitazone
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Abdominal Obesity Metabolic Syndrome

Hyperinsulinism
Hypoglycemic Agents
Mental Disorders
Mood Disorders
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Depression
Disease
Metabolic Syndrome X
Pioglitazone
Physiological Effects of Drugs
Depressive Disorder, Major
Depressive Disorder
Pharmacologic Actions

Behavioral Symptoms
Hyperinsulinism
Hypoglycemic Agents
Pathologic Processes
Mental Disorders
Syndrome
Mood Disorders
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 03, 2009