Examining how inflammation affects pleasure and motivation in older adults with anxiety
Experimental Model of Depression in Aging: Anxiety, Inflammation, and Reward Mechanisms
This study is testing how inflammation affects feelings of pleasure and motivation in older adults with anxiety compared to those with low anxiety.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05363527 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of inflammation on the reward system in older adults experiencing anxiety. Participants aged 60 to 80 will undergo a series of evaluations, including clinical interviews, questionnaires, and brain scans, to assess their responses to an experimental inflammatory challenge. The study will compare those with clinically significant anxiety to those with low anxiety, using both endotoxin and placebo interventions. Data will be collected through self-reports, computer tasks, and physiological measurements over two in-person visits and follow-up calls.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60 to 80 with clinically significant anxiety symptoms.
Not a fit: Patients with chronic mental or physical illnesses or those currently taking certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and treatment options for anxiety and related conditions in older adults.
How similar studies have performed: While studies on inflammation and mental health exist, this specific approach focusing on older adults and the reward system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * 3/4 the participants (n=30) will be those with clinically significant anxiety as defined 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-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
Where this trial is running
Los Angeles, California
- Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Chloe C Boyle, PHD — University of California, Los Angeles
- Study coordinator: Chloe C Boyle, PHD
- Email: ccboyle@mednet.ucla.edu
- Phone: 3107949383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.