Using Neuroimaging to Investigate Major Depressive Disorder

Completed

• Conditions: Major Depressive Disorder; Depression; Anxiety

• Registration Number: NCT00781677
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-29
• Primary Completion: 2009-10-20
• Study Completion: 2011-01-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment response-the Quick Inventory of Depressive Symptomatology: Clinician Rated (QIDS-SR)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Degree of comorbid anxiety-a subset of the Hamilton Rating Scale for Depression will be used to determine the anxiety/somatization factor scores	8 weeks

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States