Oral Uridine for Treatment of Bipolar Depression in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Doug Kondo, University of Utah
ClinicalTrials.gov Identifier:
NCT00841269
First received: February 9, 2009
Last updated: January 6, 2015
Last verified: January 2015
Results First Received: December 10, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Drug: Uridine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited via clinician referrals and IRB-approved recruitment materials and advertising.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    Open Label Uridine Treatment  
STARTED     7  
COMPLETED     5  
NOT COMPLETED     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Label Uridine Treatment All participants were Caucasian. There were 5 female participants and 2 male participants.

Baseline Measures
    Open Label Uridine Treatment  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     7  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  15.28  (1.49)  
Gender  
[units: participants]
 
Female     5  
Male     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     7  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures

1.  Primary:   Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment   [ Time Frame: 1 year ]

2.  Primary:   The Primary Neuroimaging Outcome Will be Changes in 3T MRS B-NTP in the Anterior Cingulate.   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   A Secondary Outcome Measure Includes a Change in YMRS Score   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Dr. Douglas Kondo
Organization: University of Utah
phone: (801) 587-1549
e-mail: doug.kondo@hsc.utah.edu


Publications of Results:

Responsible Party: Doug Kondo, University of Utah
ClinicalTrials.gov Identifier: NCT00841269     History of Changes
Other Study ID Numbers: 28455, 5R01MH058681-06
Study First Received: February 9, 2009
Results First Received: December 10, 2014
Last Updated: January 6, 2015
Health Authority: United States: Food and Drug Administration