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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Depressive Disorder, Major Metabolic Syndrome X

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Actos

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No