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Oral Uridine for Treatment of Bipolar Depression in Adolescents

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ClinicalTrials.gov Identifier: NCT00841269
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : January 8, 2015
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Douglas Kondo, MD, University of Utah

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Drug: Uridine

  Participant Flow

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)
Healthy Comparison Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention.

Participant Flow:   Overall Study
    Open Label Uridine Treatment   Healthy Comparison
STARTED   20   22 
COMPLETED   12   13 
NOT COMPLETED   8   9 



  Baseline Characteristics

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.
Healthy Comparison Participants assigned to this group were seen only at baseline and received no intervention.
Total Total of all reporting groups

Baseline Measures
   Open Label Uridine Treatment   Healthy Comparison   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   22   42 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      20 100.0%      18  81.8%      38  90.5% 
Between 18 and 65 years      0   0.0%      4  18.2%      4   9.5% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.05  (1.50)   15.67  (1.84)   15.83  (1.68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  45.0%      9  40.9%      18  42.9% 
Male      11  55.0%      13  59.1%      24  57.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      2   9.1%      2   4.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      20 100.0%      20  90.9%      40  95.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   20   22   42 


  Outcome Measures

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

2.  Primary:   The Primary Neuroimaging Outcome Will be Changes in Beta-NTP to TP (Total Phosphorus) Ratio in the Anterior Cingulate.   [ Time Frame: 6 weeks ]

3.  Secondary:   A Secondary Outcome Measure Includes a Change in Young Mania Rating Scale (YMRS) Score   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Limited sample size and small percentage of underrepresented racial/ethnic minority participants.


  More Information

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: Douglas Kondo, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00841269     History of Changes
Other Study ID Numbers: 28455
5R01MH058681-06 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2009
First Posted: February 11, 2009
Results First Submitted: December 10, 2014
Results First Posted: January 8, 2015
Last Update Posted: March 26, 2018