Clinical Trial 37764

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Los Angeles, CA 90095


Study Summary:

Volunteers with Depression needed for Sleep Deprivation Study: If you are 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 4 visits to our laboratory over the course of 1 month. One visit includes staying awake overnight in the laboratory. 
  • The study involves 2 brain scans and multiple blood draws, as well as wearing an activity-tracker and logging daily mood on your phone for 2 weeks. 

Protocol ID: IRB#15-000856    UCLA IRB Approved   Approval Date: 5/11/2017   Through: 5/10/2018   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 at least 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'll also study how sleep deprivation affects immune system and gene function by collecting samples of blood.  This research may help us  better understand how changes in the brain, in the functioning of genes, or in the immune system relate to rapid changes in depressive symptoms.

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 occur at least one day after your first visit; in this brief, 30-minute session you will have blood drawn again and be provided with a wearable device so we can record your activity and sleep behavior in the week prior to sleep deprivation. You will also be asked to complete daily mood assessments sent via text message to your personal phone. After one week of daily mood assessments, you will have visit #3, 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. 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. In the week following sleep deprivation, you will be asked to continue making daily mood and stress assessments and using the wearable device for activity and sleep behavior monitoring. After this week, you will be asked to come into the lab for visit #4, a 30-minute session in which you will return the wearable device, complete final surveys, and receive compensation. 

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:

• Patients must be diagnosed with depression and currently experiencing moderate-to-severe depression
• 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.
  • This means that patients cannot experience claustrophobia. MRI scans require being inside of a small space for up to an hour at a time.
  • This means that women who are pregnant or at risk for becoming pregnant are not eligible.

• Not be using illicit substances (including marijuana or cannabis in any form), and pass a drug test
• A letter from your current mental health provider is required acknowledging your participation in the research study
• Patients currently taking benzodiazepines must refrain from taking them at least 72 hours prior to the sleep deprivation session
• Patients and their mental health provider must live in Los Angeles


Qualified Participants May Receive:

  • Participants can earn up to $790 for completing all appointments. 


Study is Available At:

University of California Los Angeles (UCLA)
760 Westwood Plaza
Depression Grand Challenge research center
Los Angeles, CA 90095
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 25 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.