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

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ClinicalTrials.gov Identifier: NCT00671515
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : October 17, 2014
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Metabolic Syndrome X Drug: Pioglitazone Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Study Start Date : April 2008
Primary Completion Date : August 2011
Study Completion Date : November 2011


Arms and Interventions

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.
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


Outcome Measures

Primary Outcome Measures :
  1. Change in Depression Symptom Severity From Baseline to Study Endpoint [ Time Frame: Week 0 - Week 12 ]
    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


Secondary Outcome Measures :
  1. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint [ Time Frame: Week 0-Week 12 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671515


Locations
United States, Ohio
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Joseph Calabrese, MD
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Joseph E Calabrese, MD University Hospitals Cleveland Medical Center - Mood Disorders Program
More Information

Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00671515     History of Changes
Other Study ID Numbers: 07-07-20
First Posted: May 5, 2008    Key Record Dates
Results First Posted: October 17, 2014
Last Update Posted: January 26, 2017
Last Verified: November 2016

Keywords provided by Joseph Calabrese, MD, University Hospitals Cleveland Medical Center:
Depressive Disorder, Major
Metabolic Syndrome X
pioglitazone

Additional relevant MeSH terms:
Metabolic Syndrome X
Disease
Syndrome
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs