- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00671515
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
November 30, 2016 updated by: Joseph Calabrese, MD
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center - Mood Disorders Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Symptom Severity From Baseline to Study Endpoint
Time Frame: Week 0 - Week 12
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Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint.
IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
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Week 0 - Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint
Time Frame: Week 0-Week 12
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The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance.
Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin.
Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.
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Week 0-Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph E Calabrese, MD, University Hospitals Cleveland Medical Center - Mood Disorders Program
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
May 1, 2008
First Submitted That Met QC Criteria
May 1, 2008
First Posted (Estimate)
May 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Mood Disorders
- Insulin Resistance
- Hyperinsulinism
- Angina Pectoris
- Depression
- Depressive Disorder
- Syndrome
- Disease
- Metabolic Syndrome
- Depressive Disorder, Major
- Microvascular Angina
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Pioglitazone
Other Study ID Numbers
- 07-07-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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