Official Title: “Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.

Primary Measures

• IDS-CR score change from baseline to study endpoint
  • Time Frame: Week 0 - Week 12
    Safety Issue?: Yes

Secondary Measures

• Prevalence of metabolic syndrome
  • Time Frame: Week 0
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Case Medical Center

Overall Clinical Trial Officials and Contacts

David E Kemp, MD Principal Investigator University Hospitals Case Medical Center - Mood Disorders Program  

Overall Contact: Sarah Obral, BA 216-844-2869 sarah.obral@UHhospitals.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00671515

Study ID Number: 07-07-20

ClinicalTrials.gov Identifier: NCT00671515

Health Authority: United States: Institutional Review Board