Oral Administration of Uridine for the Treatment of Bipolar Depression in Adolescents

Purpose:

The study has three objectives: 1) To use Magnetic Resonance Spectroscopy (MRS) brain imaging to measure anterior cingulate cortex levels of beta-nucleoside triphosphate (b-NTP) in 30 adolescents with bipolar disorder, before-and-after 6 weeks of treatment with the investigational drug uridine; 2) To measure the antidepressant response to uridine in the 30 participants with the Children's Depression Rating Scale (CDRS); and 3) To acquire structural Magnetic Resonance Imaging (MRI) data in the 30 participants with bipolar disorder and the 30 healthy controls, to establish regionally-specific structure/neurochemical relationships.

Condition:

Bipolar Disorder

Intervention:

Oral Uridine

Study Type:

treatment

Study Design:

Open label

Primary Outcome Measures:

The primary clinical outcome measure is the Children's Depression Rating Scale (CDRS), with response defined as a 30% reduction in CDRS score. In addition to this standardized clinical assessment, participants will undergo magnetic resonance imaging and magnetic resonance spectroscopy (MRI/MRS) brain scans at baseline, and after six weeks of treatment with uridine.

Enrollment:

rolling

Assigned Interventions:

Uridine 500 mg twice daily for six weeks

Ages of Eligibility:

13 - 18

Gender:

Male and female

Inclusion Criteria:

a. Participants must meet DSM-IV-TR criteria for bipolar disorder I, II or NOS and current state depression for 2 weeks or longer.

b. Participants must be between the ages of 13 and 18 years.

c. Concomitant psychotropic medications stable for 2 weeks prior to enrollment (or not currently on psychotropic medication).

d. Subjects must be able to give informed assent or consent and parent(s) or guardian(s) must be able to give informed consent.

e. Participants with braces may be included and be treated with study drug, but will not participate in neuroimaging.

Exclusion Criteria:

a. Unstable co-morbid medical, neurological, or psychiatric disorder

b. Pregnant females or females of childbearing potential who are unable or unwilling to practice contraception during the study

c. Participants with suicidal behaviors, homicidal behaviors, or self-harm behaviors

d. Participants who in the opinion of the investigators are unlikely to be able to comply with the study protocol

e. Participants for whom an MRI/MRS scan is contraindicated, such as ferromagnetic implants or claustrophobia

f. Participants who are manic

g. Known or suspected history of mental retardation (IQ<70)

h. Known hypersensitivity to study drug or excipients

i. Positive urine drug screen for cocaine or amphetamines

Contacts:

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Tracy Hellem, RN, BSN
                                          Research Manager of the Brain Institute of the University of Utah
                                          801-587-1546
                                          tracy.hellem@hsc.utah.edu

Locations:

The University of Utah

Investigators:

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Dr. Douglas Kondo