Status:
COMPLETED
Sleep and Healthy Aging Research on Depression for Younger Women
Lead Sponsor:
University of California, Los Angeles
Conditions:
Anhedonia
Depression
Eligibility:
FEMALE
25-44 years
Phase:
PHASE1
Brief Summary
Compelling evidence indicates inflammation plays a role in depression, but potential mechanisms linking inflammation to depression, such as dysregulated reward processing, are poorly understood. This ...
Detailed Description
This study will use an inflammatory challenge (i.e., endotoxin) to assess effects of inflammation on the behavioral response to social and non-social rewards, using tasks that assess reward motivation...
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 biologically female and premenopausal (as evaluated by self report).
- Participants will 25-44 years of age.
Exclusion
- Presence of chronic mental or physical illness
- 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.
- 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
- Lifetime history of suicide attempt or inpatient psychiatric admission.
- 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
- 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.
- 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
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03848715
Start Date
October 2 2019
End Date
July 22 2024
Last Update
April 23 2025
Active Locations (1)
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1
Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles
Los Angeles, California, United States, 90095