Using Neuroimaging to Investigate Major Depressive Disorder

Depression Clinical Trial

Official title:

Using Neuroimaging to Investigate Neurobiological Correlates of Treatment Resistance Associated With Co-morbid Anxiety in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781677
• Other study ID #: Anx_Dep
• Status: Completed
• Start date: May 2008
• Est. completion date: January 20, 2011

Study information

• Verified date: February 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 20, 2011
• Est. primary completion date: October 20, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response-the Quick Inventory of Depressive Symptomatology: Clinician Rated (QIDS-SR)		8 weeks
Secondary	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