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

Primary Purpose

Depressive Disorder, Major, Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
Joseph Calabrese, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depressive Disorder, Major, Metabolic Syndrome X, pioglitazone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center - Mood Disorders Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pioglitazone

Arm Description

An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.

Outcomes

Primary Outcome Measures

Change in Depression Symptom Severity From Baseline to Study Endpoint
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
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.

Full Information

First Posted
May 1, 2008
Last Updated
November 30, 2016
Sponsor
Joseph Calabrese, MD
Collaborators
Takeda Pharmaceuticals North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00671515
Brief Title
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Official Title
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Calabrese, MD
Collaborators
Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Metabolic Syndrome X
Keywords
Depressive Disorder, Major, Metabolic Syndrome X, pioglitazone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone
Arm Type
Experimental
Arm Description
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Primary Outcome Measure Information:
Title
Change in Depression Symptom Severity From Baseline to Study Endpoint
Description
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
Time Frame
Week 0 - Week 12
Secondary Outcome Measure Information:
Title
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint
Description
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.
Time Frame
Week 0-Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Calabrese, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center - Mood Disorders Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center - Mood Disorders Program
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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