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Uridine Adolescent Bipolar Depression Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT01805440
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Douglas Kondo, MD, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Bipolar Disorder
Bipolar Depression
Manic Depression
Interventions Drug: Uridine
Drug: Placebo
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Uridine Placebo Healthy Comparison
Hide Arm/Group Description

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.

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.

Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison.
Period Title: Overall Study
Started 19 17 26
Completed 18 17 26
Not Completed 1 0 0
Arm/Group Title Uridine Placebo Healthy Comparison Total
Hide Arm/Group Description

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.

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.

Subjects seen for screening and baseline scan. No randomization or treatment intervention for subjects enrolled as a Healthy Comparison. Total of all reporting groups
Overall Number of Baseline Participants 19 17 26 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 26 participants 62 participants
<=18 years
10
  52.6%
6
  35.3%
6
  23.1%
22
  35.5%
Between 18 and 65 years
9
  47.4%
11
  64.7%
20
  76.9%
40
  64.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 26 participants 62 participants
16.74  (2.28) 18.29  (2.62) 18.54  (2.37) 17.47  (2.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 26 participants 62 participants
Female
14
  73.7%
10
  58.8%
16
  61.5%
40
  64.5%
Male
5
  26.3%
7
  41.2%
10
  38.5%
22
  35.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 17 participants 26 participants 62 participants
19 17 26 62
1.Primary Outcome
Title 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).
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Uridine Placebo Healthy Comparison
Hide Arm/Group Description:

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.

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.

Subjects did not receive study medication. Subjects were only seen for baseline visit.
Overall Number of Participants Analyzed 18 17 26
Mean (Standard Deviation)
Unit of Measure: Brain GLX/Cr
Before treatment 1.5731  (.1082) 1.6557  (.1105) 1.6051  (.1195)
After 6 weeks treatment 1.6738  (.1147) 1.6121  (.0977) NA [1]   (NA)
[1]
Subjects were healthy comparisons, and were only seen once at baseline.
2.Primary Outcome
Title Change in Children's Depression Rating Scale-Revised (CDRS-R) Score.
Hide Description The 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).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Uridine Placebo Healthy Comparison
Hide Arm/Group Description:

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.

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.

Subjects did not receive study medication. Subjects were only seen for baseline visit.
Overall Number of Participants Analyzed 18 17 26
Mean (Full Range)
Unit of Measure: Units on a scale
Total Score before treatment
59.05
(49 to 74)
58.18
(43 to 74)
21.31
(17 to 28)
Total Score after 6 weeks treatment
45.67
(30 to 74)
36.76
(21 to 64)
NA [1] 
(NA to NA)
[1]
Subjects were healthy comparisons, and were only seen once at baseline.
3.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The 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).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Uridine Placebo Healthy Comparison
Hide Arm/Group Description:

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.

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.

Subjects did not receive study medication. Subjects were only seen for baseline visit.
Overall Number of Participants Analyzed 18 17 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Participants SI Severity at Baseline 0.6875  (0.7932) 0.5882  (1.0690) 0  (0)
Participants SI Severity after 6 Weeks Treatment 0.5  (0.6183) 0.4706  (1.0676) NA [1]   (NA)
[1]
Subjects were healthy comparisons, and were only seen once at baseline.
Time Frame 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.
Adverse Event Reporting Description Healthy comparison participants were only seen at baseline, and were not exposed to any treatment intervention, therefore, adverse events were not collected.
 
Arm/Group Title Uridine Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Uridine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Uridine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      0/17 (0.00%)    
Psychiatric disorders     
Other Serious (Important Medical Event)   1/19 (5.26%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Uridine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/19 (63.16%)      5/17 (29.41%)    
Gastrointestinal disorders     
Stomach Discomfort   8/19 (42.11%)  3/17 (17.65%) 
Nausea   5/19 (26.32%)  3/17 (17.65%) 
Indicates events were collected by systematic assessment
Limited sample size and small percentage of underrepresented racial/ethnic minority participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Douglas Kondo, MD
Organization: Department of Psychiatry
Phone: 801-583-2500
Responsible Party: Douglas Kondo, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01805440     History of Changes
Other Study ID Numbers: University of Utah
First Submitted: March 1, 2013
First Posted: March 6, 2013
Results First Submitted: December 5, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018