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Completed

NCT Number: NCT00671515

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

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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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Mood Disorders Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

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.

Other names: Actos

Primary outcomes

  1. Change in Depression Symptom Severity From Baseline to Study Endpoint

    Time frame: 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 outcomes

  1. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Joseph Calabrese, MD

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 5, 2008
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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