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Uridine Adolescent Bipolar Depression Randomized Controlled Trial

NCT01805440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-03-12

Study results available
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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.

Conditions

Interventions

DRUG

Uridine

Uridine is the active treatment in this clinical trial.

DRUG

Placebo

Pill placebo is the inactive treatment comparator in this clinical trial.

Sponsors & Collaborators

  • The Depressive and Bipolar Disorder Alternative Treatment Foundation

    collaborator OTHER

  • University of Utah

    lead OTHER

Principal Investigators

  • Douglas Kondo, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805440 on ClinicalTrials.gov