Phase
Condition
Anxiety Disorders
Aging
Mood Disorders
Treatment
Placebo
Endotoxin
Clinical Study ID
Ages 60-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants will be required to be in good general health (as evaluated during thephone and in-person baseline session)
Participants will be aged 60 to 80 years.
3/4 the participants (n=30) will be those with clinically significant anxiety asdefined by a score of 5 or greater on the GAD-7;
1/4 the participants (n=10) will be those with low anxiety as defined by a GAD-7score of <5.
Exclusion
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-steroidanti-inflammatory drugs, aspirin, immune modifying drugs, opioid analgesics,statins, antihypertensive drugs, anti-arrhythmic drugs, and antidepressantmedications (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 otherautoimmune disorders;
Presence of an uncontrolled medical condition that is deemed by the investigators tointerfere with the proposed study procedures, or to put the study participant atundue risk;
Presence of chronic infection, which may elevate pro-inflammatory cytokines;
Presence of an acute infectious illness in the two weeks prior to an experimentalsession.
Current Axis I psychiatric disorders other than anxiety as determined by theResearch 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 includingsteroids;
Current and/or past regular use of non-steroid anti-inflammatory drugs;
Current and/or past regular use of immune modifying drugs that target specificimmune 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, includingantihypertensive, anti-arrhythmic, antianginal, and anticoagulant drugs;
Current smoking
Current excessive caffeine use (>600 mg/day) because of the known effects onpro-inflammatory cytokine levels;
Evidence of recreational drug use from urine test.
Body mass index > 35 because of the effects of obesity on proinflammatory cytokineactivity
Any clinically significant abnormality on screening laboratory tests
Clinically significant abnormalities in electrocardiogram
Study Design
Study Description
Connect with a study center
Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles
Los Angeles, California 90095
United StatesActive - Recruiting
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