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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01465165
• Other study ID #: WIBR08-PJC
• Status: Terminated
• Phase: N/A
• First received: November 1, 2011
• Last updated: May 18, 2017
• Start date: May 15, 2011
• Est. completion date: June 24, 2012

Study information

• Verified date: May 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 24, 2012
• Est. primary completion date: June 24, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	University of Utah Dept of Psychiatry	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Paul Carlson	Molecular Imaging Program, Huntsman Cancer Institute, University of Utah, Western Institute for Biomedical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy	relative concentration of Pcr	cross-sectional
Secondary	regional cerebral glucose metabolism, as measured by Positron Emission Tomography (PET)	binding potential of FDG	cross-sectional
Secondary	N-Acetyl-Aspartate (NAA) metabolite intensity, as measured by proton Magnetic Resonance Spectroscopy (MRS)	relative concentration of NAA	cross-sectional
Secondary	severity of depressive symptoms, as scored on the Montgomery-Asberg Depression Rating Scale (MADRS)	MADRS composite score	cross-sectional