Clinical and Imaging Biomarker Trial of Uridine for Veterans with Suicidal Ideation

Principal Investigator: Douglas Kondo
Keywords: Suicidal Ideation , Veteran , Uridine Department: Psychiatry
IRB Number: 00100075 Co Investigator: Younghoon Sung
Specialty: Psychiatry
Sub Specialties: Mood Disorders
Recruitment Status: Not yet recruiting

Contact Information

Danielle Boxer
danielle.boxer@utah.edu
385-228-3560

Brief Summary

This clinical trial is a translational brain imaging study of Uridine, as a novel treatment intervention for Veterans with suicidal ideation. The study protocol involves an acute, 4-week, randomized, placebo-controlled treatment phase that features translational proton-1 magnetic resonance spectroscopy (1H-MRS) brain scans, in order to address the following Study Objectives and Specific Aims:

 Aim 1: To Demonstrate that Uridine Decreases Suicidal Ideation in Veterans:  We hypothesize that 4 weeks of uridine 2000 mg daily will decrease the probability and severity of suicidal ideation, compared with placebo.

Aim 2. To Measure Rapid Changes in Brain GABA, in Uridine-Treated Veterans with Suicidal Ideation:  The hypothesis is that brain GABA levels, measured with magnetic resonance spectroscopy, will show a greater increase after 1 week, in uridine-treated vs. placebo-treated veterans with suicidal ideation.

Aim 3. To Examine the Durability of Uridine Treatment Response, in Veterans with Suicidal Ideation:  The hypothesis is that treatment responders will demonstrate a durable clinical response over 4 weeks, in addition to acceptable patient compliance, satisfaction and engagement.

Inclusion Criteria

The Inclusion Criteria for the study are the following:

Inclusion Criterion

Rationale

Must be able to Provide Informed Consent

Good Clinical Practice

Must be a Veteran of the U.S. Armed Forces

Population of Interest

Columbia-Suicide Severity Rating Scale Indicates Current Suicidal Ideation

Disorder of Interest

Beck Scale for Suicide Ideation Score > 4

Indicator of Significant Suicidal Ideation

History of > 1 Suicide Attempt or Hospitalization to Prevent Suicide Within the Past 12 Months or Functionally Impairing Suicidal Ideation Not Due to a DSM Axis II Diagnosis, in Past 12 Months

Minimizes Placebo Response; Justifies Treatment

Females and Males Ages 18-55 Inclusive

Matches Neuroimaging Outcome Domains

Willing and Able to Identify an Alternative Contact, e.g. Family Member or Friend

Safeguard of Participant Safety

 

Exclusion Criteria

The study's Exclusion Criteria are as follows:

Exclusion Criterion

Rationale

Schizophrenia or Other Psychotic Disorder

Requires Different Treatment

Active Substance Use Diagnosis Requiring Stabilization (N.B. Does Not Include Nicotine).

Requires Different Treatment

Unstable Medical Condition(s)

Requires Medical Treatment Before Valid Psychiatric Assessment Can Be Performed

Pregnancy or Breastfeeding

Avoid Risk to the Unborn/Breastfed Child

MRI Contraindication, e.g. Metallic Implant or Claustrophobia

Standard Procedure for Imaging Research

Concurrent Enrollment in Another Clinical Trial

Standard Procedure for Clinical Research

Significant Risk of Protocol Non-Adherence (e.g. lives >50 miles from the hospital, and has no automobile or alternate transportation).

Unethical to Impose Research Burden on Participants Likely to Drop Out or Be Withdrawn