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Status:

COMPLETED

Uridine Adolescent Bipolar Depression Randomized Controlled Trial

Lead Sponsor:

University of Utah

Collaborating Sponsors:

The Depressive and Bipolar Disorder Alternative Treatment Foundation

Conditions:

Bipolar Disorder

Bipolar Depression

Eligibility:

All Genders

13-21 years

Phase:

NA

Brief 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"). Participant...

Detailed Description

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"). In additio...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2015

    Estimated Enrollment :

    62 Patients enrolled

    Trial Details

    Trial ID

    NCT01805440

    Start Date

    August 1 2013

    End Date

    December 1 2015

    Last Update

    March 12 2018

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Utah

    Salt Lake City, Utah, United States, 84108