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Completed

NCT Number: NCT00781677

Using Neuroimaging to Investigate Major Depressive Disorder

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Treatment response-the Quick Inventory of Depressive Symptomatology: Clinician Rated (QIDS-SR)

    Time frame: 8 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Oct 29, 2008
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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