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NCT04350567 · ClinicalTrials.gov registry record · NA
Sleep/Wake Cycle and Depression: An Imaging and Treatment Study
A NA study, sponsored by Stony Brook University.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT04350567: Completed NA study, sponsored by Stony Brook University.
NCT04350567 is a NA study that has completed, run by Stony Brook University. The registered enrollment target is 61 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
NCT04350567, a NA study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
Study Summary
16.2 million American adults are affected by depression each year. The investigators are studying the relationship between sleep/wake cycle and depression. Mounting evidence suggests that abnormalities in circadian rhythms (biological changes that happen over the course of the day or night) are related to mood disorders. This may explain why people with depression frequently suffer with sleeping problems. The purpose of this study is to understand how circadian (sleep/wake) rhythms may be affected in depression and the best way to improve depression caused in this way. This will be performed by comparing circadian (sleep/wake) rhythms in people with and without depression. The study involves being kept awake for one night. For depressed individuals, this technique will likely result in a brief (\<1 day) improvement in depression. Following this study, participants with depression will be offered antidepressant medication at no cost. During the study, the investigators use brain scans to learn more about brain chemistry in health and depression.
Primary Outcome
Hypothesis 1. Average phase angle difference (DLMO - sleep midpoint) will be 6 hours (optimal) in non-depressed participants. Hypothesis 2. MDD severity (assessed by the Hamilton Depression Rating Scale, HDRS) will be correlated with deviation from optimal phase angle difference. For this hypothesis, two outcome measures (phase angle difference, in hours) and HDRS (unitless, ranges from 0 to 52, higher numbers indicate worse depression severity) will be combined in the following way: the Pearson
Interventions
- OTHER Sleep Deprivation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
What the finished NCT04350567 record still lists
NCT04350567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 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.
NCT04350567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04350567 about?
NCT04350567 is a clinical study titled "Sleep/Wake Cycle and Depression: An Imaging and Treatment Study". 16.2 million American adults are affected by depression each year. The investigators are studying the relationship between sleep/wake cycle and depression. Mounting evidence suggests that abnormalities in circadian rhythms (biological changes that happen over the course of the day or night) are rela...
What is the current status of trial NCT04350567?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2020-09-01. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT04350567?
The interventions under investigation include: Sleep Deprivation (OTHER).
Who is sponsoring clinical trial NCT04350567?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04350567's enrollment target sits among peer trials
61 1164th of 2000 higher than 837 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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