Sleep and Healthy Aging Research for Depression (SHARE-D) Study (SHARE-D)

This is an interventional other trial for Depression in Old Age focused on measuring Insomnia, depression Read More

• 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=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 Criteria: 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