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

Phase 2

Completed

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).

Recruitment & 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 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

Arm && Interventions

Group	Intervention	Description
Pioglitazone	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.

Primary Outcome Measures

Name	Time	Method
Change in Depression Symptom Severity From Baseline to Study Endpoint	Week 0 - Week 12	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

Name	Time	Method
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint	Week 0-Week 12	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.