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Use of Multiple Brain Imaging Modalities (PET and MRS) to Identify Metabolic Abnormalities in Major Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Utah.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Western Institute for Biomedical Research
University of Utah
Molecular Imaging Program, Huntsman Cancer Institute
Information provided by (Responsible Party):
Paul Carlson, University of Utah
ClinicalTrials.gov Identifier:
NCT01465165
First received: November 1, 2011
Last updated: November 3, 2011
Last verified: November 2011

November 1, 2011
November 3, 2011
June 2009
May 2012   (final data collection date for primary outcome measure)
high energy phophate metabolites (i.e., ANP and PCr) as measured by magnetic resonance spectroscopy [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465165 on ClinicalTrials.gov Archive Site
  • regional cerebral glucose metabolism, as measured by FDG PET [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
  • NAA metabolite intensity, as measured by proton MRS [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
  • severity of depressive symptoms, as scored on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Use of Multiple Brain Imaging Modalities (PET and MRS) to Identify Metabolic Abnormalities in Major Depression
Comparison of [F-18] FDG Positron Emission Tomography and Multinuclear (31P and 1H) Magnetic Resonance Spectroscopy as Complementary Bioenergetic Imaging Modalities in Healthy Human Brain and Major Depressive Disorder

Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, FDG PET and multinuclear MRS, to better understand the nature of these metabolic abnormalities in major depressive disorder (MDD). The investigators hypothesize that individuals with depression will have increased metabolic activity as measured by PET in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on MRS findings. For this study, the investigators will study 10 medication-free, currently depressed participants with recurrent MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. Depressed and healthy participants will each undergo one PET scan and one MRS scanning session.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Community sample

Major Depressive Disorder
Not Provided
  • Depressed, unmedicated
    Participants with MDD who are not treated with any antidepressant medication
  • Depressed, on antidepressant
    Participants with MDD, currently depressed but on a stable dose of an SSRI antidepressant
  • Healthy control
    Healthy participant with no MDD or other psychiatric condition, matched by age and gender to MDD participants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet DSM-IV TR criteria for MDD, Recurrent
  • Montgomery-Asberg Depression Rating Scale (MADRS) score > 18

Exclusion Criteria:

  • Any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias
  • Any history of substance dependence
  • Substance abuse within the past 6 months
  • Significant risk of suicide, as defined by score >4 on item 10 of the MADRS or in the clinical judgment of the study physician
  • Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS or PET imaging
  • For the subset of unmedicated MDD patients, any psychotropic medications within 4 weeks prior to scanning. For the subgroup of medicated patients, they may be taking a stable dose (i.e., same dose for at least 4 weeks at the time of scanning) of standard antidepressant medications, but may not be taking any other psychotropic medication.
  • Inability to give informed consent
  • Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body)
Both
18 Years to 55 Years
Yes
Contact: Paul J Carlson, M.D. 801-580-7781 Paul.Carlson@hsc.utah.edu
United States
 
NCT01465165
WIBR08-PJC
No
Paul Carlson, University of Utah
Paul Carlson
  • Western Institute for Biomedical Research
  • University of Utah
  • Molecular Imaging Program, Huntsman Cancer Institute
Principal Investigator: Paul J Carlson, M.D. University of Utah
University of Utah
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP