What is the Name of the Study?
Clinical and Imaging Biomarker Trial of Uridine for Veterans with Suicidal Ideation
What is Suicidal Ideation?
Suicidal ideation is a symptom that includes thoughts about death or wishing to be dead, as well as thinking about taking action to kill yourself. People can have one or both of these. Suicidal ideation can range from from brief consideration for a few minutes, up to extensive thoughts and detailed plans about when, where and how to end your life.
What Is Uridine?
Uridine is a naturally occurring chemical in the body, that is made by the human liver. Uridine is part of a family of compounds called pyrimidines and is involved in several important processes in the human body, such as energy metabolism and protein synthesis. Uridine is considered investigational, because it has not been proven to reduce suicidal ideation.
What is the Purpose of the Study?
Veteran completed suicides, suicide attempts, and suicidal ideation are an urgent concern for the U.S. Department of Veterans Affairs (VA). Therefore, there is an unmet need for a rapid-acting treatment for Veterans with suicidal ideation. We will use clinical assessments and magnetic resonance imaging (MRI) brain scans, to test if Uridine is effective in reducing suicidal ideation in Veterans by changing brain chemistry. MRI scans do not use radiation, and are considered safe. This study is placebo-controlled, which means half of the participants will be taking Uridine, and the other half will be taking a placebo.
What Does Uridine have to do with Suicidal Ideation?
Recently, the anesthetic drug Ketamine is being tested as rapid-acting treatment for suicidal ideation. However, Ketamine requires an intravenous (I.V.) infusion, and its effects are short-term. Ketamine also has side effects that are concerning to patients who are Veterans. In addition to Ketamine, the drug Lithium may have anti-suicidal effects. Basic science research has shown there are many similarities in how Uridine, Ketamine and Lithium work on brain cells and in animal models. This study’s goal is to learn if these effects will translate to humans.
Who Can Be in the Study?
In order to be in the study, participants must meet these criteria:
- Participants must be a Veteran of the U.S. Armed Forces
- Participants must be between the ages of 18-55
- Participants must meet criteria for significant suicidal ideation
- Participants must have a family member, friend, or other contact person
- Participants must not be pregnant or breastfeeding
- Participants must not be enrolled in another clinical trial
- Participants must be comfortable having an MRI (i.e. must not have claustrophobia or severe back pain, and must have no contraindication to MRI scans)
What Are the Benefits of Being in the Study?
We cannot promise any benefits from being in the study. However, possible benefits may include: you will receive a medical and psychiatric evaluation, and will be followed more closely than in routine clinical care. You will receive a copy of your MRI brain scan, which will be read by a board-certified radiologist. We hope that you will benefit, but this cannot be guaranteed. We do not know how Uridine will work as a treatment for Veterans with suicidal ideation. Other than direct benefits to you, there are possible indirect benefits to this research. For example, results from the study may help doctors understand how uridine affects individuals with suicidal ideation. This could help improve or develop treatments for suicidal ideation in the future. However, this would not directly benefit you.
What Do I Have to Do if I Am in the Study?
If you are interested in participating, we will schedule a screening appointment for you to meet the research staff, and to determine if you are eligible. At the screening visit, we will perform a diagnostic evaluation, including a detailed history of your suicidal ideation and suicide attempts, and also order lab testing. If you are enrolled, your second and third visits will include MRI brain scans, clinical assessments, and you will begin taking study medication. After the second MRI scan visit, you will have weekly appointments for the next 3 weeks, as you continue to take the study medication. You will stop taking the study medication after 4 weeks total. After discontinuing the study drug, we will repeat your labs, and you will have a follow-up safety visit. Altogether, you will attend 7 study appointments over 6 weeks.
Is there Compensation for this Study?
Yes; you will receive compensation for time and travel for every visit that you attend.
Can I Talk to Someone About the Study?
If you are interested in participating in the study or would like more information, please email Danielle Boxer the clinical research coordinator at: firstname.lastname@example.org, or call the research office at: (801) 587-1549.