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Clinical Trials/NCT02567110
NCT02567110
Completed
Not Applicable

Inflammation-Induced Central Nervous System (CNS) Glutamate as a Function of Depression in Middle Age

Emory University3 sites in 1 country169 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Emory University
Enrollment
169
Locations
3
Primary Endpoint
Levels of Glutamate in the basal ganglia
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to determine the impact of inflammation on central nervous system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in middle-aged patients with major depression. Depression is associated with significant alterations in glutamate concentrations and white matter integrity, which has been associated with decreased antidepressant response, poor functional outcome, and cognitive impairment.

Detailed Description

This study involves behavioral assessments, neurocognitive testing, blood sampling and magnetic resonance imaging (MRI) scanning. Goals of this study are to determine the impact of inflammation on glutamate concentrations in the basal ganglia and on the integrity of white matter tracts in the basal ganglia and other subcortical regions of middle-aged depressed versus non-depressed individuals and to associated the impact of glutamate and white matter changes on behavioral symptoms among the same group of patients.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
February 4, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ebrahim Haroon

Associate Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease as evidenced by any of the following:
  • Clinically significant abnormalities in lab values, medical history and physical exam as determined by PI or their designee
  • Changes in medications prescribed for chronic medical illnesses within past 4 weeks,
  • Hospitalization or drastic medical changes within past 4 weeks
  • Cognitive impairment as defined by:
  • Score of \< 28 on Mini-mental exam (MMSE)
  • Below 8th grade reading ability as defined by Wide Range Achievement Test-3 (WRAT3) score
  • Presence of psychosis (lifetime) / mania (current) as defined by:
  • Lifetime diagnosis of psychotic disorders SCID-V
  • SCID-V criteria for current mania/hypomania within the current episode

Outcomes

Primary Outcomes

Levels of Glutamate in the basal ganglia

Time Frame: Day 1 (Day after Screening)

Single-voxel MRS (Magnetic Resonance Spectroscopy) scans will be done to determine the glutamate levels in the basal ganglia. MRS uses a magnetic field to look at magnetic nuclei which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra, the structure and concentrations of metabolite can be determined.

Secondary Outcomes

  • Neurocognitive Testing(Day 1 (Day after Screening))
  • Hamilton Rating Scale for Depression (HAM-D-17) Score(Day 1 (Day after Screening))
  • Disease affecting white matter connecting frontal cortex to other regions of the brain(Day 1 (Day after Screening))

Study Sites (3)

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