Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
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|ClinicalTrials.gov Identifier: NCT03265964|
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : March 26, 2019
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for suicidal ideation in veterans.
The investigators hypothesize that the administration of a naturally occurring dietary supplement, uridine, will rapidly reduce suicidal ideation in veterans. The purpose of this study is to determine whether 4 weeks of uridine supplementation is an effective treatment for suicidal ideation in veterans, when compared to a group taking a placebo.
|Condition or disease||Intervention/treatment||Phase|
|Suicidal Ideation||Drug: Uridine Drug: Placebo||Phase 4|
Veteran suicides, attempts and suicidal ideation (SI) remain an urgent concern for the Veterans Health Administration (VHA). Research indicates that approximately half of veteran suicides take place within 1 month of the decedent's final VHA encounter, with one quarter occurring within 1 week. This provides a temporal window of opportunity to intervene, and necessitates development of a rapid-acting treatment for veterans with SI. Uridine shares similar brain mechanisms and neural effects with ketamin and lithium, treatments commonly used to reduce suicidal ideation. This study will test the novel intervention uridine as a rapid-acting oral treatment for veterans with suicidal ideation. The purpose of this study is to investigate whether uridine can decrease suicidal ideation in veterans when taken daily for 4 weeks.
In addition to treatment with the investigational drug versus placebo, the study includes a translational neuroimaging component: magnetic resonance spectroscopy (1H-MRS) brain scans are performed at baseline, and then repeated following 1 week of treatment with uridine or placebo. The scans do not use radiation, and are performed on a 3 Tesla MRI system that is approved for clinical use. The scans allow researchers to measure the concentrations of several chemicals in the brain that are may be involved in suicidal ideation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical and Imaging Biomarker Trial of Uridine for Veterans With Suicidal Ideation|
|Actual Study Start Date :||April 2, 2018|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||February 1, 2023|
Active Comparator: Uridine
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine is the active treatment in this clinical trial.
Other Name: Oral Uridine
Placebo Comparator: Placebo
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Pill placebo is the inactive treatment comparator in this clinical trial.
Other Name: Oral Pill Placebo
- Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 4 weeks ]The hypothesis is that 4 weeks of uridine 2000 mg daily will decrease the probability and severity of suicidal ideation measured with the C-SSRS, compared with placebo.
- Change from Baseline in Brain GABA Levels, Measured with Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging [ Time Frame: 1 week ]The hypothesis is that brain GABA levels will show a greater increase after 1 week, in uridine-treated vs. placebo-treated veterans with suicidal ideation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265964
|Contact: Douglas G Kondo, MD||(801) 582-1565 ext 2821||Douglas.Kondo@va.gov|
|Contact: Danielle Boxer, MS BA||(801) email@example.com|
|United States, Utah|
|VA Salt Lake City Health Care System, Salt Lake City, UT||Recruiting|
|Salt Lake City, Utah, United States, 84148|
|Contact: Douglas G Kondo, MD (801) 582-1565 ext 2821 Douglas.Kondo@va.gov|
|Principal Investigator: Douglas Gavin Kondo, MD|
|Principal Investigator:||Douglas Gavin Kondo, MD||VA Salt Lake City Health Care System, Salt Lake City, UT|