MRI Imaging of Chronobiologic Abnormalities in Depression

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178880
First received: September 12, 2005
Last updated: December 30, 2009
Last verified: December 2009
  Purpose

The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.


Condition Phase
Depression
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Imaging of Chronobiologic Abnormalities in Depression

Further study details as provided by Vanderbilt University:

Estimated Enrollment: 80
Study Completion Date: November 2009
Detailed Description:

The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers and depressed patients.

Criteria

Inclusion Criteria:

  • WEIGHT: less than or at 20% over ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted.
  • HEALTH: healthy, ambulatory normal or depressed adults

Exclusion Criteria:

  • Presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps.
  • Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities.
  • Pregnancy.
  • Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
  • Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
  • Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
  • Patients on antidepressants may not be taking any other medication, except at the discretion of the investigator. Untreated depressed or healthy subjects must be free of all medications except as approved by the investigator.
  • Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
  • Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178880

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37323
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Ronald M Salomon, MD Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald M. Salomon, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178880     History of Changes
Other Study ID Numbers: 010242
Study First Received: September 12, 2005
Last Updated: December 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
depression
MRI
imaging

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014