NCT00671515

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

October 17, 2014

Completed
Last Updated

January 26, 2017

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

May 1, 2008

Results QC Date

October 31, 2013

Last Update Submit

November 30, 2016

Conditions

Depressive Disorder, MajorMetabolic Syndrome X

Keywords

Depressive Disorder, MajorMetabolic Syndrome Xpioglitazone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Week 0-Week 12

Study Arms (1)

Pioglitazone

EXPERIMENTAL

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

Interventions

PioglitazoneDRUG

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

Also known as: Actos
Pioglitazone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorMetabolic Syndrome

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Joseph Calabrese
Organization
University Hospitals Cleveland Medical Center
Joseph.Calabrese@UHhospitals.org
216-844-2865

Study Officials

  • Joseph E Calabrese, MD

    University Hospitals Cleveland Medical Center - Mood Disorders Program

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Mood Disorders Program

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 5, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

January 26, 2017

Results First Posted

October 17, 2014

Record last verified: 2016-11

Locations

US(1)