CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Uridinedrug
Likely dose
Uridine 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00841269
NCT00841269Phase 2Completed

Oral Administration of Uridine for Treatment of Bipolar Depression in Adolescents: A Magnetic Resonance Spectroscopy Study

University of Utah·interventional·Posted Feb 11, 2009·Updated Mar 26, 2018

In Brief

A Phase 2 clinical trial evaluating Uridine for Bipolar Disorder. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2009
Enrollment StartMay 1, 2009
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.4 years ago

Interventions

Uridinedrug

Uridine 500 mg by mouth twice per day for 6 weeks