CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 160 enrolled
Drug / intervention
Endotoxin +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03256760
NCT03256760Phase 1Completed

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

Michael Irwin, MD·interventional·Posted Aug 22, 2017·Updated Sep 5, 2024

In Brief

A Phase 1 clinical trial evaluating Endotoxin and Placebo for Depression in Old Age. Completed, enrolled 160 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 22, 2017
Enrollment StartAug 23, 2017
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 8.9 years ago

Interventions

Endotoxinbiological

Endotoxin

Placebobiological

Placebo