Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 (Responsible Party):
Joseph Calabrese, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00671515
First received: May 1, 2008
Last updated: October 9, 2014
Last verified: October 2014
  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: 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:


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 ]
    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:
  • Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint [ Time Frame: Week 0-Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Joseph Calabrese, MD
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: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00671515     History of Changes
Other Study ID Numbers: 07-07-20
Study First Received: May 1, 2008
Results First Received: October 31, 2013
Last Updated: October 9, 2014
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
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Syndrome
Behavioral Symptoms
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Mental Disorders
Metabolic Diseases
Mood Disorders
Pathologic Processes
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014