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
Recruitment status was Recruiting
Sponsor:
University of Texas Southwestern Medical Center
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00781677
First received: October 27, 2008
Last updated: January 11, 2010
Last verified: January 2010
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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:
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 June 18, 2013