The University of California, Los Angeles is conducting a clinical trial that examines the effect of inflammatory challenges on insomnia in elderly patients with depression. After participants are assessed, researchers are attempting to offer treatment based on their results.
Since chronic inflammatory and insomnia can lead to depression in some older adults, researchers are seeing if reducing an inflammatory change in patients with insomnia can produce results. The study will compare two groups of 80 elderly participants, those with and those without insomnia, and examine the result similarities and differences.
- All sexes, ages 60 to 80 years old
- Currently in good general health, evaluated by pre-screening process
- Half the participants will be required to be currently diagnosed with insomnia disorder
- The other half will be required to be determined not to have insomnia disorder
- Presence of chronic mental or physical illness (except for insomnia)
- 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)
- Night shift work or time zone shifts within the previous 6 weeks before study
- Previous history of fainting during blood draws.
- Presence of comorbid medical conditions 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 uncontrolled medical condition(s) that may interfere with study
- Presence of chronic infection
- Presence of an acute infectious illness in the two weeks before study
- Currently have an Axis I psychiatric disorder including major depressive order or substance dependence
- Lifetime history of suicide attempt or inpatient psychiatric admission
- Currently have sleep apnea or nocturnal myoclonus
- Have phase-shift disorder
- Current and/or past regular use of cardiovascular medications
- Use of antidepressant medications or other psychotropic medications
- Excessive caffeine intake
- Recreational drug users
- Body mass index greater than 35
- Abnormalities in electrocardiogram
The study is being held at the Cousins Center for Psychoneuroimmunology at UCLA Neuropsychiatric Institute in Los Angeles California, 90095. If you have any questions feel free to contact Michael Irwin, MD, at 310-825-8281 or at email@example.com. You may also contact Hyong Cho, MD, PhD at 310-260-7492 or at firstname.lastname@example.org.
This clinical trial is sponsored by the University of California, Los Angeles. The Principal Investigator is Michael Irwin, MD.
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