Trial Outcomes & Findings for Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation (NCT NCT03265964)
NCT ID: NCT03265964
Last Updated: 2025-08-15
Results Overview
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. Scores range from 0 to 25 with higher scores representing more severe suicidal ideation.
COMPLETED
PHASE4
75 participants
4 weeks
2025-08-15
Participant Flow
Participant milestones
| Measure |
Uridine
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
|
Overall Study
COMPLETED
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation
Baseline characteristics by cohort
| Measure |
Uridine
n=37 Participants
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=38 Participants
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40.89 years
STANDARD_DEVIATION 8.33 • n=99 Participants
|
37.65 years
STANDARD_DEVIATION 7.14 • n=107 Participants
|
39.29 years
STANDARD_DEVIATION 7.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Participants who were non-adherent to the study protocol or had medication changes throughout the clinical trial were removed from this analysis.
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. Scores range from 0 to 25 with higher scores representing more severe suicidal ideation.
Outcome measures
| Measure |
Uridine
n=29 Participants
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=26 Participants
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Week 0
|
13.69 score on a scale
Standard Deviation 2.04
|
14.46 score on a scale
Standard Deviation 2.73
|
|
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
End of Treatment: Week 4
|
8.27 score on a scale
Standard Deviation 6.45
|
10.87 score on a scale
Standard Deviation 5.20
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Participants who were non-adherent to the study protocol or had medication changes throughout the clinical trial were removed from this analysis.
The hypothesis is that 4 weeks of uridine 2000 mg daily will decrease the probability and severity of suicidal ideation measured with the BSSI compared with placebo. The BSSI is a 19 item measure on a 0-2 point scale for a range of 0-38, with higher scores indicating higher suicidal ideation or worse outcomes.
Outcome measures
| Measure |
Uridine
n=29 Participants
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=26 Participants
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Change From Baseline in Beck Scale for Suicide Ideation (BSSI)
Baseline: Week 0
|
14.52 score on a scale
Standard Deviation 4.26
|
17 score on a scale
Standard Deviation 5.78
|
|
Change From Baseline in Beck Scale for Suicide Ideation (BSSI)
End of Treatment: Week 4
|
6.35 score on a scale
Standard Deviation 6.37
|
10.57 score on a scale
Standard Deviation 7.26
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Statistical outliers and motion-corrupted neuroimaging data were removed from this analysis.
The hypothesis is that Brain Gamma-Aminobutyric Acid (GABA)/NAA levels will show a greater increase after 1 week, in uridine-treated vs. placebo-treated veterans with suicidal ideation. Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) is a safe and non-invasive method for in-vivo measurement of brain chemistry relevant to mental health, including the neurotransmitters, glutamate, glutamine, and GABA.
Outcome measures
| Measure |
Uridine
n=31 Participants
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=33 Participants
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Change From Baseline in Brain Gamma-Aminobutyric Acid (GABA)/NAA Levels, Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging
|
0.00113 ratio of GABA/NAA
Standard Deviation 0.0327
|
0.00564 ratio of GABA/NAA
Standard Deviation 0.0279
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Statistical outliers and motion-corrupted neuroimaging data were removed from this analysis.
Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) is a safe and non-invasive method for in-vivo measurement of brain chemistry relevant to mental health, including the neurometabolites, choline and N-acetylaspartate.
Outcome measures
| Measure |
Uridine
n=31 Participants
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=33 Participants
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Change From Baseline in Brain Total Choline/N-acetylaspartate (NAA) Levels, Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging
|
0.00461 ratio of tCho/NAA
Standard Deviation 0.012
|
-0.00117 ratio of tCho/NAA
Standard Deviation 0.0106
|
Adverse Events
Uridine
Placebo
Serious adverse events
| Measure |
Uridine
n=37 participants at risk
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=38 participants at risk
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation/Behavior
|
0.00%
0/37 • 4 weeks
|
2.6%
1/38 • 4 weeks
|
Other adverse events
| Measure |
Uridine
n=37 participants at risk
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=38 participants at risk
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal cramp, Nausea, Indigestion, Diarrhea
|
35.1%
13/37 • 4 weeks
|
36.8%
14/38 • 4 weeks
|
|
Nervous system disorders
Headache, lightheadedness
|
13.5%
5/37 • 4 weeks
|
15.8%
6/38 • 4 weeks
|
|
Psychiatric disorders
Psychiatric
|
5.4%
2/37 • 4 weeks
|
10.5%
4/38 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
2.7%
1/37 • 4 weeks
|
10.5%
4/38 • 4 weeks
|
Additional Information
Dr. Douglas Kondo
VA Salt Lake City Health Care System, VISN 19 Rocky Mountain MIRECC for Veteran Suicide Prevention
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place