Depression in Type 2 Diabetes
Recruitment status was Recruiting
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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 |
| 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 |
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.
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| Contact: Monya Meinel, BA, CCRC | 312-996-6201 | mmeinel@psych.uic.edu |
| 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 | |
| Principal Investigator: | Anand Kumar, MD | University of Illinois |
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:
|
Depression Diabetes Mellitus |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Diabetes Mellitus Diabetes Mellitus, Type 2 Behavioral Symptoms |
Mood Disorders Mental Disorders Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013