Summary:
Male Volunteers with Depression needed for Sleep Deprivation Study:
If you are a male experiencing moderate-to-severe depression for at least six months and are between 20-64 years old, you may be eligible to participate in a total sleep deprivation study at UCLA.
Our study is looking at how one night of sleep deprivation relates to changes in mood, brain chemistry and function, and gene regulation.
The study involves 2 visits to our laboratory over the course of 2 weeks. One visit includes staying awake overnight in the laboratory.
The study involves 2 brain scans and multiple blood draws.
Protocol ID: IRB#15-000856
UCLA IRB Approved
Approval Date: 3/16/2021 Through: 1/13/2022
Committee: Medical IRB 3
This research study will examine how total sleep deprivation might work in the treatment of depression. In this study, sleep deprivation means you will be asked to remain awake for atleast 23 hours, under continual observation, at our research center. We cannot know if any individual patient will respond to sleep deprivation when used for depression. We will study how sleep deprivation affects brain structure and function by collecting brain scans, and we'llalso study how sleep deprivation affects immune system and gene function by collectingsamples of blood. This research may help us better understand how changes in the brain, inthe functioning of genes, or in the immune system relate to rapid changes in depressivesymptoms.
Participation starts with a phone screening, followed by visit #1 at UCLA, which lasts several hours and includes a psychiatric evaluation, standard laboratory tests, a blood draw, and collection of a urine sample. If results indicate you are eligible for receiving sleep deprivation, you will then be scheduled for visit #2, which will last approximately 31 hours, spanning two days and one night. During the first several hours of this visit, you will receive one brain scan and complete some questionnaires and computer tasks. You will then be checked into a research unit for overnight observation where you will be kept awake for the entire duration of the visit. During this time, you will complete mood evaluations at regular intervals and provide 5 separate blood samples. During this time, you can read, watch movies, use a computer, talk to staff, and will be provided with snacks and meals. You will be required to remain upright under constant lighting conditions and will be prohibited from lying down or falling asleep for the entire duration. After 23 hours in the research unit, you will receive a second brain scan and again complete some questionnaires and computer tasks. One week after the sleep deprivation session, you will be asked to complete a brief survey online about your mood since your last visit.
This research study is being conducted with support from the UCLA Depression Grand Challenge and the National Institute of Mental Health Human Connectome Project, which aims to acquire and share data about the structural and functional connectivity underlying human brain function as well as disease. For this reason, we will give access to some of the data, including MR images and most behavioral data, to the general public via the internet or other investigators that have been approved by the study researchers. Your data will be coded and will not have your name on it. Letting us use and share your data is voluntary, however, you must be willing to share your data in this way in order to participate in this study. If you are not willing, you cannot participate in this research study.
Qualified Participants Must:
• Be diagnosed with depression and currently experiencing moderate-to-severe depression
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Be able to undergo MRI scanning. This means that patients cannot:
- Have any metal implants, such as a pacemaker,aneurysm clip, non-removable piercings, or permanent retainers.
- Experience claustrophobia. MRI scans require beinginside of a small space for up to an hour at a time.
- Be pregnant. Women who are pregnant or at risk for becoming pregnant are not eligible.
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Not be using illicit substances (including marijuana or cannabis in any form), and pass a drug test
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Patients currently taking benzodiazepines must refrain from taking them at least 72 hours prior to the sleep deprivation session. A letter from the patient’s provider stating that it is safe for them to stop taking this medication for this period of time for the sake of participating in this research study will be required.
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Patients and their mental health provider must live in Los Angeles
Qualified Participants May Receive:
Participants can earn up to $700 for completing all appointments