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NCT02270619 · ClinicalTrials.gov registry record · Early Phase 1
Sleep Health, Inflammation, and Emotion Study
A Early Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 95
- Enrollment target
NCT02270619 is a Early Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 95 participants.
The verdict
NCT02270619, a Early Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 95 participants
- Enrollment target
Study 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 therapies have limited effectiveness; hence, biologically plausible models for new treatments are being pursued. Systemic inflammation is hypothesized to play an important role on the onset and perpetuation of depression, especially in older women. Aging processes involve a heightened inflammatory state, and both inflammatory disorders and depression are more prevalent in women than men. However, increased systemic inflammation does not necessarily lead to depression in all women. Even when robust systemic inflammation is experimentally induced (e.g. endotoxin administration), largely variable increases in depressive symptoms are found. Defining the factors that account for this variability may identify individuals at risk of developing depression when exposed to heightened inflammatory states such as aging, obesity, and chronic disease, and informs future translational studies of depression prevention. In particular, the role of sleep disturbance in explaining this variability requires further attention because it is an independent risk factor for depression and heightens systemic inflammation by increasing the production of proinflammatory cytokines. The investigators have also discovered that women, but not men, who report sleep disturbance including short sleep duration experience significantly more depressive symptoms in response to an inflammatory challenge than women without sleep disturbance. Thus, it is hypothesized that sleep loss is a vulnerability factor for inflammation-induced depressive symptoms in women. However, to date, no experimental approach has been used to evaluate the role of sleep loss on inflammation-induced depressive symptoms. This proposal aims to examine this hypothesis by partial sleep deprivation (PSD) followed by endotoxin challenge in older wo
Interventions
- OTHER Placebo
- BIOLOGICAL Endotoxin
- BEHAVIORAL Partial sleep deprivation
- OTHER Uninterrupted sleep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2014-10 |
| Est. Completion | 2021-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02270619
The ClinicalTrials.gov registry entry for NCT02270619 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02270619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02270619 about?
NCT02270619 is a clinical study titled "Sleep Health, Inflammation, and Emotion Study". 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 therapies have limited effectiveness; hence, biologically plausible models for new treatments are being pur...
What is the current status of trial NCT02270619?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 95 participants. The study started on 2014-10. Estimated completion is 2021-01.
What interventions are being tested in trial NCT02270619?
The interventions under investigation include: Placebo (OTHER), Endotoxin (BIOLOGICAL), Partial sleep deprivation (BEHAVIORAL), Uninterrupted sleep (OTHER).
Who is sponsoring clinical trial NCT02270619?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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