Oral Uridine for Treatment of Bipolar Depression in Adolescents
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Intervention: Uridine
Intervention description: Uridine 500 mg by mouth twice per day for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bipolar Manic Depression

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.
    

Eligibility 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