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

Study Overview
=================
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).

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

Conditions
-----------------
Depressive Disorder, Major, Metabolic Syndrome X

Intervention / Treatment
-----------------
* Drug: Pioglitazone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pioglitazone<br>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<br>* An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.<br>* Other names: Actos;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depressive Disorder, Major, Metabolic Syndrome X, pioglitazone