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Aging and Reward System Response to Inflammation and Anxiety Study

About

Brief Summary

The purpose of this study is to use an experimental inflammatory challenge to examine whether older adults with symptoms of anxiety experience loss of pleasure or loss of motivation when they are exposed to inflammation. Loss of pleasure or loss of motivation will be evaluated using self-report questionnaires, computer tasks, and during a brain scan.

Primary Purpose
Other
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
60 Years
Maximum Age
80 Years

Inclusion Criteria:

  • Participants will be required to be in good general health (as evaluated during the phone and in-person baseline session)
  • Participants will be aged 60 to 80 years.
  • Half the participants (n=40) will be those with clinically significant anxiety as defined by a score of 5 or greater on the GAD-7;
  • Half the participants (n=40) will be those with low anxiety as defined by a GAD-7 score of <5.

Exclusion Criteria:

  • Presence of chronic mental or physical illness (except for anxiety)
  • History of allergies, autoimmune, liver, or other severe chronic diseases
  • Current and regular use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, aspirin, immune modifying drugs, opioid analgesics, statins, antihypertensive drugs, anti-arrhythmic drugs, and antidepressant medications (none in the last 6 months)
  • Nightshift work or time zone shifts (> 3hrs) within the previous 6 weeks
  • Previous history of fainting during blood draws.
  • Claustrophobia
  • Metal in the body
  • Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders;
  • Presence of comorbid inflammatory disorders such as rheumatoid arthritis or other autoimmune disorders;
  • Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk;
  • Presence of chronic infection, which may elevate pro-inflammatory cytokines;
  • Presence of an acute infectious illness in the two weeks prior to an experimental session.
  • Current Axis I psychiatric disorders other than anxiety as determined by the Research Version of the Structured Clinical Interview
  • Lifetime history of suicide attempt or inpatient psychiatric admission.
  • Sleep Disorders: Current history of sleep apnea or nocturnal myoclonus;
  • Phase-shift disorder
  • Current and/or past regular use of hormone-containing medications including steroids;
  • Current and/or past regular use of non-steroid anti-inflammatory drugs;
  • Current and/or past regular use of immune modifying drugs that target specific immune responses such as cytokine antagonists;
  • Current and/or past regular use of analgesics such as opioids;
  • Current and/or past regular use of cardiovascular medications, including antihypertensive, anti-arrhythmic, antianginal, and anticoagulant drugs;
  • Current smoking
  • Current excessive caffeine use (>600 mg/day) because of the known effects on pro-inflammatory cytokine levels;
  • Evidence of recreational drug use from urine test.
  • Body mass index > 35 because of the effects of obesity on proinflammatory cytokine activity
  • Any clinically significant abnormality on screening laboratory tests
  • Clinically significant abnormalities in electrocardiogram

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Study Stats
Protocol No.
21-001246
Category
Healthy Volunteers
Mental Health
Principal Investigator
CHLOE BOYLE
Contact
CHLOE BOYLE
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05363527
For detailed technical eligibility, visit ClinicalTrials.gov.