Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
Primary Purpose
Suicidal Ideation
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Uridine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicidal Ideation, Veteran, Uridine, Neuroimaging
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).
Sites / Locations
- VA Salt Lake City Health Care System, Salt Lake City, UTRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Uridine
Placebo
Arm Description
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Outcomes
Primary Outcome Measures
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
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
Change from Baseline in Brain GABA Levels, Measured with Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging
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.
Full Information
NCT ID
NCT03265964
First Posted
August 25, 2017
Last Updated
March 22, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03265964
Brief Title
Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
Official Title
Clinical and Imaging Biomarker Trial of Uridine for Veterans With Suicidal Ideation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Suicidal Ideation, Veteran, Uridine, Neuroimaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Uridine
Arm Type
Active Comparator
Arm Description
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Uridine
Other Intervention Name(s)
Oral Uridine
Intervention Description
Uridine is the active treatment in this clinical trial.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Oral Pill Placebo
Intervention Description
Pill placebo is the inactive treatment comparator in this clinical trial.
Primary Outcome Measure Information:
Title
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Brain GABA Levels, Measured with Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas G Kondo, MD
Phone
(801) 582-1565
Ext
2821
Email
doug.kondo@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Boxer, MS BA
Phone
(801) 587-1549
Email
danielle.boxer@utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Gavin Kondo, MD
Organizational Affiliation
VA Salt Lake City Health Care System, Salt Lake City, UT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas G Kondo, MD
Phone
(801) 582-1565
Ext
2821
Email
doug.kondo@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Douglas Gavin Kondo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21486171
Citation
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Results Reference
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21176029
Citation
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Results Reference
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18540779
Citation
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Results Reference
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PubMed Identifier
15705349
Citation
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Results Reference
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PubMed Identifier
20043005
Citation
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PubMed Identifier
19262950
Citation
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PubMed Identifier
25088943
Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Links:
URL
https://www.google.com/patents/US20110160158
Description
Methods of treatment of bipolar disorder [US Patent Application 20110160158 A1]
Learn more about this trial
Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
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