Status:
COMPLETED
Sleep Health, Inflammation, and Emotion Study
Lead Sponsor:
University of California, Los Angeles
Conditions:
Depression
Eligibility:
FEMALE
60-80 years
Phase:
EARLY_PHASE1
Brief Summary
Late-life depression is a major public health burden due to its high prevalence and associated morbidity, suicide risk, functional decline, and mortality. Unfortunately, current antidepressant therapi...
Eligibility Criteria
Inclusion
- to be in good general health
- to be female
- to be aged 60 to 80 years
Exclusion
- presence of chronic mental or physical illnesses
- history of allergies, auto-immune, liver, or other chronic diseases
- current use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, immune modifying drugs, opioid analgesics, and psychotropic medications
- current sleep disorders such as insomnia or sleep apnea
- nightshift work or time zone shifts (\> 3 hours) within the previous 6 weeks
- an Axis I psychiatric disorder as determined by the Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) including a current or within 1 year prior-to-study history of major depressive disorder (a history of depression 1 or more years prior to the study is not an exclusion criterion, which will be considered for a pre-planned sensitivity analysis, however, any prior depressive episode severe enough to have involved suicidal ideation or required an inpatient psychiatric admission is an exclusion criterion)
- prior or current suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- current depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9) (≥ 5)
- sleep disorders identified by the SCID and the Duke Structured Interview for Sleep Disorders (DSISD)
- sleep disturbance defined by the Pittsburgh Sleep Quality Index (PSQI) (≥ 5)
- a positive screen for sleep apnea using the Berlin Sleep Apnea Questionnaire
- excessive caffeine use (\>600 mg/day)
- BMI \> 35 due to the effects of obesity on cytokine activity and risk for sleep disordered breathing
- evidence of recreational drug use from urine test
- any abnormalities on screening laboratory tests.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT02270619
Start Date
October 1 2014
End Date
January 1 2021
Last Update
February 18 2021
Active Locations (1)
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1
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, United States, 90095