Oral Uridine for Treatment of Bipolar Depression in Adolescents

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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 the human liver. Uridine is part of a family of compounds called pyrimidines, and is normally involved in many of the body's processes such as the use of energy by cells. Uridine is considered experimental, because it has not been approved by the U.S. Food and Drug Administration (FDA) to treat bipolar depression in adolescents. The study will use standard methods of assessing adolescent's mood, such as rating scales and questionnaires. In addition, the study will use Magnetic Resonance Imaging Spectroscopy (MRI/MRS) brain scans to see if levels of certain chemicals in the brain change when adolescents are treated with uridine. These scans use a magnet to create images of the brain, and do not expose patients to radiation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: National Institute of Mental Health (NIMH)

Criteria

Selection of Participants with Bipolar Disorder:

Inclusion Criteria:

• 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 Criteria:

• 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

Exclusion Criteria:

• Clinically significant medical, neurological, psychiatric or substance abuse disorder

• Pregnant subjects, due to the unknown effects of MRI/MRS scans on a fetus. In addition, women of childbearing potential who are unable or unwilling to practice contraception during the study will be excluded. Female participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS scan.

• Participants with a contraindication to MRI/MRS scanning, such as a metallic implant

• Patients unable to comply with the protocol