Magnetic Resonance Spectroscopy (MRS) in Midlife Depression

NCT02567110 | Completed DMC

• 2 other identifiers: IRB000834645R01MH107033-04
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression; Depression Bipolar

Keywords

Mid-life Depression; Bipolar Disorder; DSM-5 MDE; Inflammation; CNS Glutamate

Outcome Measures

Primary Outcomes (1)

• Levels of Glutamate in the basal ganglia

  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.

  Day 1 (Day after Screening)

Secondary Outcomes (3)

• 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 Arms (2)

Participants with Major Depression

Participants with major depression will complete neurocognitive and psychiatric assessments, complete self-report forms and undergo Magnetic Resonance Imaging scans. Blood and spinal fluid specimens will also be collected for estimation of inflammatory markers.

Participants without Depression

Participants without depression will complete neurocognitive and psychiatric assessments, complete self-report forms and undergo Magnetic Resonance Imaging scans. Blood and spinal fluid specimens will also be collected for estimation of inflammatory markers.

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients who have a diagnosis of depression or bipolar depression and men and women without a diagnosis of depression or bipolar depression in the control group

You may qualify if:

• Willing and able to give written informed consent
• Meet criteria for Major Depression per DSM-V criteria using Structured Clinical Interview for DSM-V (SCID-V) and a score ≧18 on the 17-item Hamilton Rating Scale for Depression (HAMD).
• Absence of significant suicidal ideation, determined by the Columbia Suicide Severity Rating Scale - Screen Version (CSSRS)
• Meets MRI scanning safety requirements:
• Absence of embedded MR-unsafe metallic objects
• Location and quantity of MR-safe metallic objects will minimally impact rigor/reproducibility standards of the MR data (as determined by the PI in consultation with the neuroimaging team)
• Criteria for major depression not met per the SCID-V
• HAMD scores ≦7
• Absence of any Axis I pathology

You may not qualify if:

• 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
• Clinically significant substance abuse within the past 6 months as defined by meeting the SCID-V threshold of severity for \> 4/11 criteria for substance abuse disorder
• Presence of active symptoms of an eating disorder as defined by:
• SCID-V diagnosis of Anorexia or bulimia nervosa.
• Presence of significant psychiatric comorbidities during current episode:
• Primary diagnosis of anxiety-spectrum disorders (panic, generalized anxiety, social phobia etc.), PTSD, OCD based on SCID-V criteria

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital Clinical Research Network

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

inflammatory gene expression studies, APOE4 genotyping

MeSH Terms

Conditions

Depression; Bipolar Disorder; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebrahim Haroon, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 2, 2015
• Study Start: July 1, 2016
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

US (3)