Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation

January 8, 2024 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148-0001
        • VA Salt Lake City Health Care System, Salt Lake City, UT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Uridine
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Drug: Uridine
Uridine is the active treatment in this clinical trial.
Other Names:
  • Oral Uridine
Placebo Comparator: Placebo
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Drug: Placebo
Pill placebo is the inactive treatment comparator in this clinical trial.
Other Names:
  • Oral Pill Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Douglas Gavin Kondo, MD, VA Salt Lake City Health Care System, Salt Lake City, UT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBB-012-16F
  • 00100075 (Other Identifier: Salt Lake City VAMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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