NCT03256760

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

Experimental Model of Depression in Aging: Insomnia, Inflammation, and Affect Mechanisms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Michael Irwin, MD · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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 prevention, and this study is significant in using an experimental approach (i.e., inflammatory challenge) to probe acute inflammatory- and depression responses as a function of insomnia, which will inform identification of molecular targets for pharmacologic interventions, and improvement of insomnia treatments to prevent depression in older adults. Project

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 adults with insomnia show chronic inflammation; sleep disturbance also activates inflammatory signaling; chronic inflammation primes acute inflammatory responses; chronic inflammation, as well as acute inflammatory reactivity, predict depression over the following year; and finally, endotoxin induces acute inflammation along with depressive symptoms, with preliminary evidence that "two-hits" (i.e., sleep disturbance and inflammatory challenge) are associated with exaggerated increases in depression, especially in women. In this placebo-controlled, randomized, double-blind study of low dose endotoxin in older adults (60-80 y; stratified by sex) with insomnia (n=60) vs. comparisons without insomnia (n=100), the investigators hypothesize that older adults with insomnia will show heightened inflammatory- and affective responding to inflammatory challenge as compared to those without insomnia. The investigation aims to: 1) examine differences in depressive symptoms and measures of negative affect responding as a function of insomnia and inflammatory challenge; 2) examine differences in measures of positive affect responding as a function of insomnia and inflammatory challenge; and 3) examine differences in experimentally-induced inflammation in relation to depressive symptoms and measures of negative- and positive affect responding as a function of insomnia.

Conditions

• Depression in Old Age

Interventions

Type	Name	Description
BIOLOGICAL	Endotoxin	Endotoxin
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2017-08-23
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2017-08-22
• Last updated: 2024-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study