Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Information source: University Hospital Case Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major; Metabolic Syndrome X
Intervention: Pioglitazone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital Case Medical Center Official(s) and/or principal investigator(s):
David E Kemp, MD, Principal Investigator, Affiliation: University Hospitals Case Medical Center - Mood Disorders Program
Overall contact:
Sarah Obral, BA, Phone: 216-844-2869, Email: sarah.obral@UHhospitals.org
Summary
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).
Clinical Details
Official title: Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: IDS-CR score change from baseline to study endpoint
Secondary outcome: Prevalence of metabolic syndrome
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Sarah Obral, BA, Phone: 216-844-2869, Email: sarah.obral@UHhospitals.org
University Hospitals Case Medical Center - Mood Disorders Program, Cleveland, Ohio 44106, United States; Recruiting
Sarah Obral, BA, Phone: 216-844-2869, Email: sarah.obral@UHhospitals.org
David E Kemp, MD, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: January 2010
Last updated: July 17, 2009
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