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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00671515
First received: May 1, 2008
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Metabolic Syndrome X
 Drug: Pioglitazone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Change in depression symptom severity from baseline to study endpoint [ Time Frame: Week 0 - Week 12 ] [ Designated as safety issue: Yes ]
    IDS-CR score change from baseline to study endpoint


Secondary Outcome Measures:
  • Prevalence of metabolic syndrome [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    Number of participants who meet criteria for Metabolic Syndrome at baseline.


Enrollment: 40
Study Start Date: April 2008
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671515

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

No publications provided

Responsible Party: David E. Kemp, MD, University Hospital Case Medical Center - Mood Disorders Program
ClinicalTrials.gov Identifier: NCT00671515     History of Changes
Other Study ID Numbers: 07-07-20
Study First Received: May 1, 2008
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Depressive Disorder, Major
Metabolic Syndrome X
pioglitazone

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

ClinicalTrials.gov processed this record on May 21, 2013