Overview

Uridine Adolescent Bipolar Depression Randomized Controlled Trial

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar depression"). Participants initially randomized to placebo who complete the 6-week protocol will be offered 6 months of open-label uridine treatment and follow-up. Participants initially randomized to uridine will be offered the open-label treatment as well.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Utah
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Criteria
Inclusion Criteria For Bipolar Disorder Participants:

- Participants under 18 years of age must be able to provide assent, and have the
permission of a parent or guardian. Participants 18 years of age or older must be able
to provide informed consent.

- Participants must be between the ages of 13 and 21 years.

- Participants must meet DSM criteria for Bipolar Disorder (Type I, II, or NOS), with
current mood state depressed for at least 2 weeks.

- Participants must have a current Children's Depression Rating Scale-Revised (CDRS-R)
score of 45 or greater, and/or a Montgomery/Asberg Depression Rating Scale (MADRS)
score of 25 or greater.

Inclusion Criteria For Healthy Comparison Participants:

- Participants under 18 years of age must be able to provide assent, and have the
permission of a parent or guardian. Participants 18 years of age or older must be able
to provide informed consent.

- Participants must be between the ages of 13 and 21 years.

- Participants must not meet any DSM-IV criteria for a psychiatric illness or substance
use disorder

Exclusion Criteria:

- Participants must not meet DSM criteria for a primary psychotic disorder, a
developmental disorder or substance use disorder.

- Participants must not be at high risk for suicidal or homicidal actions.

- Participants must not be pregnant or breastfeeding.

- Participants must not have a contraindication to magnetic resonance imaging (e.g.
ferromagnetic implant, or claustrophobic anxiety).

- Incarcerated persons are excluded, because this study is not approved for Research
Involving Prisoners.