Clinical trial NCT03265964: Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
Official title: Clinical and Imaging Biomarker Trial of Uridine for Veterans With Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Suicidal Ideation
Keywords: Suicidal Ideation
Veteran
Uridine
Neuroimaging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-08-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Must be able to Provide Informed Consent.
* Must be a Veteran of the U.S. Armed Forces.
* Columbia-Suicide Severity Rating Scale Indicates Current Suicidal Ideation
* Beck Scale for Suicide Ideation Score \> 3 (i.e. "Greater Than or Equal to 4").
* History of \> 1 Suicide Attempt or Hospitalization to Prevent Suicide in Past 12 Months; or Functionally Impairing Suicidal Ideation Not Due to a DSM Axis II Diagnosis, in the Past 12 Months.
* Females and Males Ages 18-55 Inclusive.
* Willing and Able to Identify an Alternative Contact Person, e.g. Family Member, Friend or Neighbor.

Exclusion Criteria:

* Schizophrenia or Other Psychotic Disorder.
* Active Substance Use Disorder Requiring Stabilization (N.B. Does Not Include Nicotine).
* Unstable Medical Condition(s).
* Pregnancy or Breastfeeding.
* Contraindication to MRI (e.g. Ferrometallic Implant or Claustrophobic Anxiety).
* Concurrent Enrollment in Another Clinical Trial.
* Significant Risk of Protocol Non-Adherence (e.g. resides \> 50 miles from the hospital, and has no automobile or alternate transportation).

Primary outcomes:
measure: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from Baseline in Brain GABA Levels, Measured with Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging
timeFrame: 1 week
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
name: Douglas Gavin Kondo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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