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Depression in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Illinois at Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01327404
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

The purpose of the study is to examine the relationship between brain structure and depression in adults aged 30 or older with Diabetes. This relationship is determined using magnetic resonance imaging technology (MRI), a scanner with a magnet that is used to create images of the brain.


Condition
Depression
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Myelin, Glia and Depression in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Estimated Enrollment: 400
Study Start Date: October 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Depressed
Patients with Major Depressive Disorder
Diabetic
Patients with Type 2 Diabetes
Diabetic/Depressed
Patients with both diabetes and major depressive disorder
Healthy Controls

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients of all subject types will be recruited through the general medical, psychiatric, and endocrinology clinics associated with the UIC Medical Center. Patients will be first cleared for participation in the study by their primary physicians. The patient and family will be approached by the PI or another investigator who will explain the research and its goals. We also plan to recruit subjects through flyers and advertisements.

Criteria

Inclusion Criteria:

  • Age: 30 to 80 years old
  • Diagnosis of type 2 diabetes
  • Diagnosis of major depressive disorder using standard diagnostic and statistical manual (DSM) criteria
  • Score of 15 or greater on the 17-item Hamilton Depression rating scale
  • Mini Mental Status Exam score of 24 or greater
  • No evidence of clinical dementia or any other clinical brain disorder
  • Free of psychotropic/psychoactive medications for at least 2 weeks
  • First episode of depression diagnosed either after or around the time type 2 diabetes was diagnosed since we are interested in the relationship between the cerebrovascular effect of diabetes and the pathophysiology of major depression

Exclusion Criteria:

  • Presence of dementia or any other clinical brain disorder (Parkinson's, Alzheimer's)
  • Mini Mental Status Exam score of less than 24
  • Unstable medical illness (grade 4 on the Cumulative Illness Rating Scale)
  • Presence of any metallic implant that would preclude an MRI scan (pacemaker, etc.)
  • Concurrent Axis 1 disorder (schizophrenia, bipolar)
  • Use of atypical neuroleptics for the current episode and/or strong clinical suspicion that the diabetes is secondary to the use of atypical neuroleptics;
  • Recurrent major depression, operationally defined as two or more, well-characterized episodes of depression, prior to the onset/diagnosis of diabetes
  • Seizure disorder
  • Stroke/Transient Ischemic Attack
  • Central nervous system disorder (multiple sclerosis)
  • Trauma to head/Loss of Consciousness
  • Claustrophobia
  • Eating disorder (anorexia, bulimia)
  • Weight of over 350 pounds
  • Learning disorder (dyslexia, ADHD)
  • Psychosis, panic or anxiety disorder outside the context of depression
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327404

Contacts
Contact: Monya Meinel, BA, CCRC 312-996-6201 mmeinel@psych.uic.edu

Locations
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Monya Meinel, BA, CCRC    312-996-6201    mmeinel@psych.uic.edu   
Contact: Piotr Daranowski, MA    312-413-8223    pdaranowski@psych.uic.edu   
Principal Investigator: Anand Kumar, MD         
Sub-Investigator: Olusola Ajilore, MD, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Anand Kumar, MD University of Illinois at Chicago
  More Information

Additional Information:
Publications:
Responsible Party: Anand Kumar, MD, Head of Psychiatry, University of Illinois
ClinicalTrials.gov Identifier: NCT01327404     History of Changes
Other Study ID Numbers: 2009-0473, 5R01MH063764
Study First Received: March 30, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Depression
Diabetes Mellitus

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014