Phase 4 N=75 Randomized Triple-blind Treatment

Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation

Suicidal Ideation

Bottom Line

View on ClinicalTrials.gov: NCT03265964 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Aug 2025

Primary outcome: Primary: Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) — 13.69; 14.46; 8.27; 10.87 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Uridine (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)	13.69; 14.46; 8.27; 10.87	—
PRIMARY Change From Baseline in Beck Scale for Suicide Ideation (BSSI)	14.52; 17; 6.35; 10.57	—
PRIMARY Change From Baseline in Brain Gamma-Aminobutyric Acid (GABA)/NAA Levels, Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging	0.00113; 0.00564	—
SECONDARY Change From Baseline in Brain Total Choline/N-acetylaspartate (NAA) Levels, Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging	0.00461; -0.00117	—

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03265964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.