Trial Outcomes & Findings for Oral Uridine for Treatment of Bipolar Depression in Adolescents (NCT NCT00841269)
NCT ID: NCT00841269
Last Updated: 2018-03-26
Results Overview
The CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-03-26
Participant Flow
Participants were recruited via clinician referrals and IRB-approved recruitment materials and advertising.
Participant milestones
| Measure |
Open Label Uridine Treatment
Participants received fixed-dose uridine 500 mg twice daily for 6 weeks. At each treatment visit, the following rating scales were administered: The CDRS-R, YMRS, and the Columbia-Suicide Severity Rating Scale (C-SSRS)
|
Healthy Comparison
Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Uridine for Treatment of Bipolar Depression in Adolescents
Baseline characteristics by cohort
| Measure |
Open Label Uridine Treatment
n=20 Participants
All participants were Caucasian. There were 5 female participants and 2 male participants.
|
Healthy Comparison
n=22 Participants
Participants assigned to this group were seen only at baseline and received no intervention.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.05 years
STANDARD_DEVIATION 1.50 • n=5 Participants
|
15.67 years
STANDARD_DEVIATION 1.84 • n=7 Participants
|
15.83 years
STANDARD_DEVIATION 1.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.
Outcome measures
| Measure |
Healthy Comparison
n=13 Participants
Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
|
Open Label Uridine Treatment
n=12 Participants
Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
|
|---|---|---|
|
Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment
before treatment
|
21.29 Units on a scale
Interval 17.0 to 35.0
|
60.00 Units on a scale
Interval 40.0 to 82.0
|
|
Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment
after 6 week Uridine treatment
|
20 Units on a scale
Interval 17.0 to 25.0
|
33.83 Units on a scale
Interval 20.0 to 59.0
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Healthy Comparison
n=13 Participants
Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
|
Open Label Uridine Treatment
n=12 Participants
Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
|
|---|---|---|
|
The Primary Neuroimaging Outcome Will be Changes in Beta-NTP to TP (Total Phosphorus) Ratio in the Anterior Cingulate.
Before treatment
|
0.1232 Beta-NTP/TP Ratio
Standard Deviation 0.0127
|
0.1168 Beta-NTP/TP Ratio
Standard Deviation 0.0157
|
|
The Primary Neuroimaging Outcome Will be Changes in Beta-NTP to TP (Total Phosphorus) Ratio in the Anterior Cingulate.
After 6 weeks treatment
|
0.1297 Beta-NTP/TP Ratio
Standard Deviation 0.0140
|
0.1193 Beta-NTP/TP Ratio
Standard Deviation 0.0142
|
SECONDARY outcome
Timeframe: 6 weeksThe Young Mania Rating Scale (YMRS) is an 11-item rating scale that evaluates manic symptoms. Total scores range from 0-60, with higher scores indicating more manic symptoms endorsed by research participants.
Outcome measures
| Measure |
Healthy Comparison
n=13 Participants
Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
|
Open Label Uridine Treatment
n=12 Participants
Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
|
|---|---|---|
|
A Secondary Outcome Measure Includes a Change in Young Mania Rating Scale (YMRS) Score
Before treatment
|
0.7083 units on a scale
Interval 0.0 to 6.0
|
5.42 units on a scale
Interval 2.0 to 11.0
|
|
A Secondary Outcome Measure Includes a Change in Young Mania Rating Scale (YMRS) Score
After 6 weeks treatment
|
2.1818 units on a scale
Interval 0.0 to 9.0
|
3.08 units on a scale
Interval 0.0 to 7.0
|
Adverse Events
Uridine 500 mg by Mouth Twice Daily for 6 Weeks
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Uridine 500 mg by Mouth Twice Daily for 6 Weeks
n=20 participants at risk
Because this was an open-label study, all participants received the investigational drug uridine.
|
|---|---|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
Other adverse events
| Measure |
Uridine 500 mg by Mouth Twice Daily for 6 Weeks
n=20 participants at risk
Because this was an open-label study, all participants received the investigational drug uridine.
|
|---|---|
|
Psychiatric disorders
suicidal ideation
|
5.0%
1/20 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • Number of events 4 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
Gastrointestinal disorders
Abdominal cramp, Nausea, Indigestion
|
30.0%
6/20 • Number of events 10 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
General disorders
Flu-like symptoms (fatigue, bronchitis, sinusitis)
|
30.0%
6/20 • Number of events 7 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
Eye disorders
Hordeolum
|
5.0%
1/20 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
General disorders
Back pain
|
5.0%
1/20 • 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 for scans at baseline and week 6. Healthy comparison participants were not exposed to any treatment intervention, therefore, adverse events were not collected.
|
|
Psychiatric disorders
Vivid Dreams
|
5.0%
1/20 • 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 for scans at baseline and week 6. Healthy comparison participants 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