Advanced MRI in Major Depression

Depressive Disorder, Major Clinical Trial

Official title:

Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613912
• Other study ID #: AUFF-2005-740-004
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: November 18, 2011
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg Hospital / Aarhus University Hospital	Aalborg	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in morphological and functional cerebral MRI findings in patients suffering from major depression		6 months from first MRI in each patient	No