Using Neuroimaging to Investigate Major Depressive Disorder
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Depression; Anxiety
Phase: N/A
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Frank A Kozel, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center
Overall contact:
Kimberly Mapes, Phone: 214-648-0157, Email: Kimberly.Mapes@UTSouthwestern.edu
Summary
The purpose of this neuroimaging study is to investigate the brain correlates of Major
Depressive Disorder with anxiety symptoms as well as potentially identify predictors of
treatment outcome.
Clinical Details
Official title: Using Neuroimaging to Investigate Neurobiological Correlates of Treatment Resistance Associated With co-Morbid Anxiety in Major Depressive Disorder
Study design: Case-Only, Prospective
Primary outcome: Treatment response-the Quick Inventory of Depressive Symptomatology: Clinician Rated (QIDS-SR)
Secondary outcome: Degree of comorbid anxiety-a subset of the Hamilton Rating Scale for Depression will be used to determine the anxiety/somatization factor scores
Detailed description:
The purpose of this study is to test whether the structural and functional connectivity
between the dorso-lateral prefrontal cortex (DLPFC) and amygdala will decline as symptoms of
co-morbid anxiety (Anxiety Factor Score) increase in patients with MDD. This decrease in
connectivity will also account for decrease in treatment response. The structural
connectivity will be assessed using Diffusion Tensor Imaging (DTI) and the functional
connectivity will be assessed using resting state BOLD fMRI. We propose to use the fMRI and
DTI to identify biological markers that are associated with treatment response in a cohort
of patients with a spectrum of Anxiety Factor Scores.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Competent to give informed consent
- Diagnosis of Major Depressive Disorder
- Males and females
- Ages 18-50 years old
- All races and ethnicities
- Able to read, speak, and understand English*
Exclusion Criteria:
- History of psychiatric illness except Major Depressive Disorder, Generalized Anxiety
Disorder, Social Phobia, or Specific Phobia
- Alcohol or substance abuse within the last 6 months or alcohol or substance
dependence within the last year
- Diagnosis of an organic brain disease
- Serious unstable medical illness
- History of serious head injury
- Unsafe or unable to have an MRI or previous inability to tolerate MRI
- Pregnancy or breast feeding
Locations and Contacts
Kimberly Mapes, Phone: 214-648-0157, Email: Kimberly.Mapes@UTSouthwestern.edu
University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Kimberly Mapes, Phone: 214-648-0157, Email: Kimberly.Mapes@UTSouthwestern.edu
Additional Information
Starting date: May 2008
Ending date: May 2010
Last updated: February 27, 2009
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