Status:
COMPLETED
Oral Uridine for Treatment of Bipolar Depression in Adolescents
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
13-18 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to see if the investigational medication uridine reduces depression symptoms in adolescents with bipolar disorder. Uridine is a naturally occurring chemical that is made by...
Detailed Description
This is an open-label study of the investigational drug uridine in the treatment of adolescents with depression with bipolar disorder. Uridine has shown positive results in a Phase II study of bipolar...
Eligibility Criteria
Inclusion
- Selection of Participants with Bipolar Disorder:
- Participants must meet DSM-IV-TR (American Psychiatric Association, 2000) criteria for Bipolar Disorder Type I, Type II, or Not Otherwise Specified (NOS) with current mood state depressed for \> 2 weeks
- Participants must be between the age of 13 and 18 years
- Participants who enter the study on psychotropic medications must be on a regimen that has been stable for \> 2 weeks at the time of study entry
- Participants must be able to give informed consent or assent, and parent(s)/guardian(s) must be able to give informed permission for study participation
Exclusion
- Adolescents with an unstable co-morbid medical, neurological, or psychiatric disorder
- Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice contraception during the study
- Participants with high risk of suicidal behaviors, homicidal behaviors, or self-harm
- Participants who in the opinion of the investigator are unlikely to be able to comply with the study protocol
- Participants who meet DSM-IV-TR criteria for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence
- Participants for whom the MRI/MRS scans are contraindicated, such as children with ferromagnetic implants or claustrophobia
- Participants whose mood state is manic
- Documented or suspected history of mental retardation (IQ\<70)
- Positive urine drug screen for cocaine or amphetamines
- Known hypersensitivity to uridine
- Selection of Healthy Volunteers:
- Inclusion Criteria:
- Participants must be between the ages of 13 and 18 years
- Participants must not meet DSM-IV-TR diagnostic criteria for a mental disorder or substance abuse
- Participants must be able to give informed consent or assent and parents/guardians must be able to give informed permission for participation
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00841269
Start Date
May 1 2009
End Date
June 1 2013
Last Update
March 26 2018
Active Locations (1)
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1
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84108