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Advanced MRI in Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00613912
First received: January 31, 2008
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

Depression is the most common psychiatric disorder.

  • 3-5% of a given population has major depression.
  • Less than 50% of the depressed in Denmark are diagnosed with major depression.
  • 25-50% of the depressed have a relative with major depression-underlying brain pathology?

The purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression


Condition Intervention
Depressive Disorder, Major
 Other: Magnetic Resonance Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Differences in morphological and functional cerebral MRI findings in patients suffering from major depression [ Time Frame: 6 months from first MRI in each patient ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Ambulant patients with major depression
 Other: Magnetic Resonance Imaging
  • Morphological sequences
  • Arterial Spin Labelling (Perfusion)
  • Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter
Other Name: 3 Tesla GE Scanner HDx

Detailed Description:

Previous studies within major depression, have often included hospitalized patients with severe symptoms and imaging have been performed with PET and SPECT, which uses ionizing radiation. This study focus on ambulant patients(with or without medication/ECT treatment), to find patients in an earlier stage. Cerebral perfusion with the MR sequence Arterial Spin Labelling, concentrations of different metabolites with MR spectroscopy and brain volumetry with BRAVO 3D T1 ax will be performed.

MR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg hospital-Århus University Hospital.

Criteria

Inclusion Criteria:

  • Patients who fulfil ICD-10´s criteria for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18

Exclusion Criteria:

  • If the patient has pacemaker or other magnetic devices
  • Pregnancy
  • Has had an operation in the brain
  • bipolar disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613912

Locations
Denmark
Aalborg Hospital / Aarhus University Hospital
Aalborg, Jutland, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Elna-Marie B Larsson, Professor Uppsala University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00613912     History of Changes
Other Study ID Numbers: AUFF-2005-740-004
Study First Received: January 31, 2008
Last Updated: November 18, 2011
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain

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

ClinicalTrials.gov processed this record on May 23, 2013