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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671515
• Other study ID #: 07-07-20
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2008
• Last updated: October 9, 2014
• Start date: April 2008
• Est. completion date: November 2011

Study information

• Verified date: October 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 a-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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Metabolic Syndrome X
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center - Mood Disorders Program	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Joseph Calabrese, MD	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 0 - Week 12	Yes
Secondary	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.	Week 0-Week 12	No