Status:
COMPLETED
Sleep and Healthy Aging Research for Depression (SHARE-D) Study
Lead Sponsor:
Michael Irwin, MD
Conditions:
Depression in Old Age
Eligibility:
All Genders
60-80 years
Phase:
PHASE1
Brief Summary
Late-life depression is a significant public health concern, and effective interventions for prevention and treatment are needed. Insomnia and inflammation are modifiable targets for depression preven...
Detailed Description
This study (SHARE-D) will use an inflammatory challenge (i.e., endotoxin) to probe acute inflammatory- and depression responses (primary outcome) in older adults as a function of insomnia. Older adult...
Eligibility Criteria
Inclusion
- 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=80) will be those with insomnia disorder as diagnosed by the Structured Clinical Interview for Diagnosis, Diagnostic Statistical Manual 5 and the Duke Structured Interview for Sleep Disorders, .
- The other half will be those without insomnia identified as not having insomnia by any of these assessments.
Exclusion
- Following a structured telephone interview, prospective participants with the following conditions will not advance to the in-person baseline session:
- 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); and nightshift work or time zone shifts (\> 3hrs) within the previous 6 weeks, or previous history of fainting during blood draws.
- 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 proinflammatory cytokines;
- Presence of an acute infectious illness in the two weeks prior to an experimental session.
- Current Axis I psychiatric disorders as determined by the Research Version of the Structured Clinical Interview including a current major depressive disorder and substance dependence (a prior history of depression is not an exclusion criterion, which will be considered for a pre-planned sensitivity analysis and will be used as a pre-classification variable in the generation of the two groups, and in the randomization schedule);
- Lifetime history of suicide attempt or inpatient psychiatric admission. Sleep Disorders:
- Current history of sleep apnea or nocturnal myoclonus;
- Phase-shift disorder, which will be identified by the Structured Clinical Interview and the Duke Structured Interview for Sleep Disorders ; Medication and Substance Use:
- 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, antiarrhythmic, antianginal, and anticoagulant drugs;
- Use of antidepressant medications or other psychotropic medications; (16) current smoking or excessive caffeine use (\>600 mg/day) because of the known effects on proinflammatory cytokine levels;
- Evidence of recreational drug use from urine test. Health Factors:
- Body mass index \> 35 because of the effects of obesity on proinflammatory cytokine activity and also on risk for sleep disordered breathing;
- Any clinically significant abnormality on screening laboratory tests
- Clinically significant abnormalities in electrocardiogram
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03256760
Start Date
August 23 2017
End Date
April 30 2024
Last Update
September 5 2024
Active Locations (1)
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1
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095