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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465165
Recruitment Status : Terminated (Study procedures were not feasible.)
First Posted : November 4, 2011
Last Update Posted : May 19, 2017
Western Institute for Biomedical Research
University of Utah
Molecular Imaging Program, Huntsman Cancer Institute
Information provided by (Responsible Party):
Paul Carlson, University of Utah

Brief Summary:
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, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear magnetic resonance spectroscopy (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 or disease
Major Depressive Disorder

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Magnetic Resonance Spectroscopy (MRS) as Bioenergetic Imaging Modalities in Healthy Human Brain and Major Depressive Disorder
Actual Study Start Date : May 15, 2011
Actual Primary Completion Date : June 24, 2012
Actual Study Completion Date : June 24, 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy [ Time Frame: cross-sectional ]
    relative concentration of Pcr

Secondary Outcome Measures :
  1. regional cerebral glucose metabolism, as measured by Positron Emission Tomography (PET) [ Time Frame: cross-sectional ]
    binding potential of FDG

  2. N-Acetyl-Aspartate (NAA) metabolite intensity, as measured by proton Magnetic Resonance Spectroscopy (MRS) [ Time Frame: cross-sectional ]
    relative concentration of NAA

  3. severity of depressive symptoms, as scored on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: cross-sectional ]
    MADRS composite score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample

Inclusion Criteria:

  • Meet DSM-IV criteria for Major Depressive Disorder (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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465165

United States, Utah
University of Utah Dept of Psychiatry
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
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

Responsible Party: Paul Carlson, Assistant Professor, University of Utah Identifier: NCT01465165     History of Changes
Other Study ID Numbers: WIBR08-PJC
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified scanning images may be individually examined after the study is completed if new analysis methods become available to collaborators.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Paul Carlson, University of Utah:
Positron emission tomography
Magnetic resonance spectroscopy
glucose metabolism

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs