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NCT03256760 · ClinicalTrials.gov registry record · Phase 1
Sleep and Healthy Aging Research for Depression (SHARE-D) Study
A Phase 1 study, sponsored by Michael Irwin, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
NCT03256760: Completed Phase 1 study, sponsored by Michael Irwin, MD.
NCT03256760 is a Phase 1 study that has completed, run by Michael Irwin, MD. The registered enrollment target is 160 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03256760, a Phase 1 study, has completed, sponsored by Michael Irwin, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
Study 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
Primary Outcome
The Depressed Mood Subscale of the POMS is a self-and observer rated assessment of depressed mood in which severity of depressed mood is rated using a visual analog scale from 1 to 5 (5 being most severe). Each timepoint is scored and analyses examine the temporal profile of change with assessment every hour
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Endotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 1 |
What the finished NCT03256760 record still lists
NCT03256760 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03256760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03256760 about?
NCT03256760 is a clinical study titled "Sleep and Healthy Aging Research for Depression (SHARE-D) Study". 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)...
What is the current status of trial NCT03256760?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2017-08-23. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT03256760?
The interventions under investigation include: Placebo (BIOLOGICAL), Endotoxin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03256760?
This trial is sponsored by Michael Irwin, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03256760's enrollment target sits among peer trials
160 340th of 2000 higher than 1,655 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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