Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major; Metabolic Syndrome X
Intervention: Pioglitazone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Joseph Calabrese, MD Official(s) and/or principal investigator(s): David E Kemp, MD, Principal Investigator, Affiliation: University Hospitals Case Medical Center - Mood Disorders Program
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: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Depression Symptom Severity From Baseline to Study Endpoint
Secondary outcome: Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint
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
University Hospitals Case Medical Center - Mood Disorders Program, Cleveland, Ohio 44106, United States
Additional Information
Starting date: April 2008
Last updated: October 9, 2014
|