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
  Purpose

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.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • high energy phophate metabolites (i.e., ANP and PCr) as measured by magnetic resonance spectroscopy [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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)
  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: NCT01465165

Contacts
Contact: Paul J Carlson, M.D. 801-580-7781 Paul.Carlson@hsc.utah.edu

Locations
United States, Utah
University of Utah Dept of Psychiatry Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Paul J Carlson, M.D.    801-580-7781    Paul.Carlson@hsc.utah.edu   
Principal Investigator: Paul J Carlson, M.D.         
Sponsors and Collaborators
Paul Carlson
Western Institute for Biomedical Research
University of Utah
Molecular Imaging Program, Huntsman Cancer Institute
Investigators
Principal Investigator: Paul J Carlson, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Paul Carlson, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01465165     History of Changes
Other Study ID Numbers: WIBR08-PJC
Study First Received: November 1, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Depression
Positron emission tomography
Magnetic resonance spectroscopy
glucose metabolism
ATP
phosphocreatine

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014