Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/28/2019 |
| Start Date: | April 2, 2018 |
| End Date: | February 1, 2023 |
| Contact: | Douglas G Kondo, MD |
| Email: | Douglas.Kondo@va.gov |
| Phone: | (801) 582-1565 |
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.
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.
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.
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.
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).
We found this trial at
1
site
Salt Lake City, Utah 84148
Principal Investigator: Douglas Gavin Kondo, MD
Phone: (801) 582-1565
Click here to add this to my saved trials
