Using Neuroimaging to Investigate Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University of Texas Southwestern Medical Center. Recruitment status was Recruiting

First Received on October 27, 2008. Last Updated on January 11, 2010 History of Changes

Sponsor:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00781677

Purpose

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.

Condition
Major Depressive Disorder Depression Anxiety

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:

MedlinePlus related topics: Anxiety Depression

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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)

Groups/Cohorts
MDD

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

community sample

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781677

Contacts

Contact: Kimberly Mapes

214-648-0157

Kimberly.Mapes@UTSouthwestern.edu

Locations

United States, Texas
University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Kimberly Mapes 214-648-0157 Kimberly.Mapes@UTSouthwestern.edu

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

Frank A Kozel, MD

University of Texas Southwestern Medical Center

More Information

No publications provided

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

Keywords provided by University of Texas Southwestern Medical Center:

Major Depressive Disorder
Depression
Anxiety

Additional relevant MeSH terms:

Anxiety Disorders
Depression
Depressive Disorder
Depressive Disorder, Major

Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on February 09, 2012