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Using Neuroimaging to Investigate Major Depressive Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: October 27, 2008
Last updated: January 11, 2010
Last verified: January 2010
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.

Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using Neuroimaging to Investigate Neurobiological Correlates of Treatment Resistance Associated With Co-morbid Anxiety in Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Treatment response-the Quick Inventory of Depressive Symptomatology: Clinician Rated (QIDS-SR) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Degree of comorbid anxiety-a subset of the Hamilton Rating Scale for Depression will be used to determine the anxiety/somatization factor scores [ Time Frame: 8 weeks ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00781677

Contact: Kimberly Mapes 214-648-0157

United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kimberly Mapes    214-648-0157   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Frank A Kozel, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Frank Andrew Kozel, M.D., M.S.C.R., University of Texas Southwestern Medical Center Identifier: NCT00781677     History of Changes
Other Study ID Numbers: Anx_Dep
Study First Received: October 27, 2008
Last Updated: January 11, 2010

Keywords provided by University of Texas Southwestern Medical Center:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Anxiety Disorders
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders processed this record on May 25, 2017