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NCT03169543 · ClinicalTrials.gov registry record · NA
Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03169543: Completed NA study, sponsored by University of Pennsylvania.
NCT03169543 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03169543, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and SD. Here we propose to study a group of N=48 antidepressant-free male and female patients with current depression symptom and N=12 healthy controls with no history of mood disorders before and after SD to provide mechanistic insight into the neural substrates underlying the antidepressant effects of SD. We hypothesize that SD-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total SD, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.
Primary Outcome
Total score on a modified Hamilton Depression Inventory that assesses mood symptoms in the moment.
Interventions
- BEHAVIORAL Sleep deprivation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2020-02-28 |
| Phase | NA |
What the finished NCT03169543 record still lists
NCT03169543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Sleep deprivation is the first listed.
NCT03169543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03169543 about?
NCT03169543 is a clinical study titled "Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation". From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate...
What is the current status of trial NCT03169543?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2016-04-01. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT03169543?
The interventions under investigation include: Sleep deprivation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03169543?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03169543's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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