Trial Outcomes & Findings for Uridine Adolescent Bipolar Depression Randomized Controlled Trial (NCT NCT01805440)
NCT ID: NCT01805440
Last Updated: 2018-03-12
Results Overview
Magnetic Resonance Spectroscopy is a safe, non-invasive method for measuring brain chemicals thought to be involved in mood disorders, such as GLX (glutamate + glutamine). Previous research indicates that adolescents with bipolar depression have elevated Glx concentrations, compared with controls. The measurement of Glx with 1H-MRS has the potential to identify translational biomarkers of juvenile BD pathophysiology and treatment response.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2018-03-12
Participant Flow
Participant milestones
| Measure |
Uridine
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
Healthy Comparison
Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
26
|
|
Overall Study
COMPLETED
|
18
|
17
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uridine Adolescent Bipolar Depression Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Uridine
n=19 Participants
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=17 Participants
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
Healthy Comparison
n=26 Participants
Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
16.74 years
STANDARD_DEVIATION 2.28 • n=99 Participants
|
18.29 years
STANDARD_DEVIATION 2.62 • n=107 Participants
|
18.54 years
STANDARD_DEVIATION 2.37 • n=206 Participants
|
17.47 years
STANDARD_DEVIATION 2.54 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
17 participants
n=107 Participants
|
26 participants
n=206 Participants
|
62 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksMagnetic Resonance Spectroscopy is a safe, non-invasive method for measuring brain chemicals thought to be involved in mood disorders, such as GLX (glutamate + glutamine). Previous research indicates that adolescents with bipolar depression have elevated Glx concentrations, compared with controls. The measurement of Glx with 1H-MRS has the potential to identify translational biomarkers of juvenile BD pathophysiology and treatment response.
Outcome measures
| Measure |
Uridine
n=18 Participants
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=17 Participants
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
Healthy Comparison
n=26 Participants
Subjects did not receive study medication. Subjects were only seen for baseline visit.
|
|---|---|---|---|
|
Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS).
Before treatment
|
1.5731 Brain GLX/Cr
Standard Deviation .1082
|
1.6557 Brain GLX/Cr
Standard Deviation .1105
|
1.6051 Brain GLX/Cr
Standard Deviation .1195
|
|
Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS).
After 6 weeks treatment
|
1.6738 Brain GLX/Cr
Standard Deviation .1147
|
1.6121 Brain GLX/Cr
Standard Deviation .0977
|
NA Brain GLX/Cr
Standard Deviation NA
Subjects were healthy comparisons, and were only seen once at baseline.
|
PRIMARY outcome
Timeframe: 6 weeksThe CDRS-R is a brief rating scale based on a semi-structured interview with the participant (and/or their parent or guardian). The scale can be administered and scored in under 30 minutes. The CDRS-R gives you a single summary score -- with an interpretation of, and clinical recommendations for, six different score ranges. Total possible scores range from 17 to 113, with higher scores indicating more depressive symptoms reported by the participant (and/or their parent or guardian).
Outcome measures
| Measure |
Uridine
n=18 Participants
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=17 Participants
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
Healthy Comparison
n=26 Participants
Subjects did not receive study medication. Subjects were only seen for baseline visit.
|
|---|---|---|---|
|
Change in Children's Depression Rating Scale-Revised (CDRS-R) Score.
Total Score before treatment
|
59.05 Units on a scale
Interval 49.0 to 74.0
|
58.18 Units on a scale
Interval 43.0 to 74.0
|
21.31 Units on a scale
Interval 17.0 to 28.0
|
|
Change in Children's Depression Rating Scale-Revised (CDRS-R) Score.
Total Score after 6 weeks treatment
|
45.67 Units on a scale
Interval 30.0 to 74.0
|
36.76 Units on a scale
Interval 21.0 to 64.0
|
NA Units on a scale
Subjects were healthy comparisons, and were only seen once at baseline.
|
SECONDARY outcome
Timeframe: 6 weeksThe Columbia-Suicide Severity Rating Scale (C-SSRS) is used to measure suicidal thoughts and behaviors in Investigational New Drug (IND) studies. The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Outcome measures
| Measure |
Uridine
n=18 Participants
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=17 Participants
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
Healthy Comparison
n=26 Participants
Subjects did not receive study medication. Subjects were only seen for baseline visit.
|
|---|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants SI Severity at Baseline
|
0.6875 Scores on a Scale
Standard Deviation 0.7932
|
0.5882 Scores on a Scale
Standard Deviation 1.0690
|
0 Scores on a Scale
Standard Deviation 0
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants SI Severity after 6 Weeks Treatment
|
0.5 Scores on a Scale
Standard Deviation 0.6183
|
0.4706 Scores on a Scale
Standard Deviation 1.0676
|
NA Scores on a Scale
Standard Deviation NA
Subjects were healthy comparisons, and were only seen once at baseline.
|
Adverse Events
Uridine
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Uridine
n=19 participants at risk
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=17 participants at risk
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Psychiatric disorders
Other Serious (Important Medical Event)
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
0.00%
0/17 • Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
Other adverse events
| Measure |
Uridine
n=19 participants at risk
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine: Uridine is the active treatment in this clinical trial.
|
Placebo
n=17 participants at risk
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Placebo: Pill placebo is the inactive treatment comparator in this clinical trial.
|
|---|---|---|
|
Gastrointestinal disorders
Stomach Discomfort
|
42.1%
8/19 • Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
17.6%
3/17 • Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
17.6%
3/17 • Adverse events were collected from participants at every visit, starting after the treatment intervention was dispensed at baseline. Adverse events were assessed up to 6 weeks.
Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place