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

This study has been completed.

First Received on May 1, 2008. Last Updated on December 13, 2011 History of Changes

Sponsor:	University Hospital Case Medical Center
Collaborator:	Takeda Pharmaceuticals North America, Inc.
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:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

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

Secondary Outcome Measures:

Prevalence of metabolic syndrome [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
Number of participants who meet criteria for Metabolic Syndrome at baseline.

Enrollment:	40
Study Start Date:	April 2008
Study Completion Date:	November 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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 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

Locations

United States, Ohio
University Hospitals Case Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospital Case Medical Center

Takeda Pharmaceuticals North America, Inc.

Investigators

Principal Investigator:

David E Kemp, MD

University Hospitals Case Medical Center - Mood Disorders Program

More Information

No publications provided

Responsible Party:	David E. Kemp, MD, University Hospital Case Medical Center - Mood Disorders Program
ClinicalTrials.gov Identifier:	NCT00671515 History of Changes
Other Study ID Numbers:	07-07-20
Study First Received:	May 1, 2008
Last Updated:	December 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:

Depressive Disorder, Major
Metabolic Syndrome X
pioglitazone

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Metabolic Syndrome X
Mood Disorders
Mental Disorders
Behavioral Symptoms
Insulin Resistance

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

ClinicalTrials.gov processed this record on February 09, 2012