Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 26 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Utah, United States ) | NIH, U.S. Fed

Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03265964
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Suicidal Ideation Drug: Uridine Drug: Placebo Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical and Imaging Biomarker Trial of Uridine for Veterans With Suicidal Ideation
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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 Name: 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 Name: Oral Pill Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265964


Contacts
Layout table for location contacts
Contact: Douglas G Kondo, MD (801) 582-1565 ext 2821 Douglas.Kondo@va.gov
Contact: Danielle Boxer, MS BA (801) 386-4953 danielle.boxer@utah.edu

Locations
Layout table for location information
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Douglas G Kondo, MD    (801) 582-1565 ext 2821    Douglas.Kondo@va.gov   
Principal Investigator: Douglas Gavin Kondo, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Douglas Gavin Kondo, MD VA Salt Lake City Health Care System, Salt Lake City, UT

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03265964     History of Changes
Other Study ID Numbers: MHBB-012-16F
00100075 ( Other Identifier: Salt Lake City VAMC )
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by VA Office of Research and Development:
Suicidal Ideation
Veteran
Uridine
Neuroimaging

Additional relevant MeSH terms:
Layout table for MeSH terms
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms