NCT01327404

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

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

October 19, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2014

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

March 30, 2011

Last Update Submit

May 14, 2025

Conditions

Keywords

DepressionDiabetes Mellitus

Study Arms (4)

Depressed

Patients with Major Depressive Disorder

Diabetic

Patients with Type 2 Diabetes

Diabetic/Depressed

Patients with both diabetes and major depressive disorder

Healthy Controls

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

  • Ajilore O, Narr K, Rosenthal J, Pham D, Hamilton L, Watari K, Elderkin-Thompson V, Darwin C, Toga A, Kumar A. Regional cortical gray matter thickness differences associated with type 2 diabetes and major depression. Psychiatry Res. 2010 Nov 30;184(2):63-70. doi: 10.1016/j.pscychresns.2010.07.003. Epub 2010 Sep 15.

  • Nguyen TT, Wong TY, Islam FM, Hubbard L, Ajilore O, Haroon E, Darwin C, Esser B, Kumar A. Evidence of early retinal microvascular changes in patients with type 2 diabetes and depression. Psychosom Med. 2010 Jul;72(6):535-8. doi: 10.1097/PSY.0b013e3181da90f4. Epub 2010 Apr 5.

  • Kumar A, Gupta R, Thomas A, Ajilore O, Hellemann G. Focal subcortical biophysical abnormalities in patients diagnosed with type 2 diabetes and depression. Arch Gen Psychiatry. 2009 Mar;66(3):324-30. doi: 10.1001/archgenpsychiatry.2008.548.

  • Watari K, Elderkin-Thompson V, Ajilore O, Haroon E, Darwin C, Pham D, Kumar A. Neuroanatomical correlates of executive functioning in depressed adults with type 2 diabetes. J Clin Exp Neuropsychol. 2008 May;30(4):389-97. doi: 10.1080/13803390701440486.

Related Links

MeSH Terms

Conditions

DepressionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anand Kumar, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

October 19, 2009

Primary Completion

October 7, 2014

Study Completion

November 1, 2014

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations