NCT01805440

Uridine Adolescent Bipolar Depression Randomized Controlled Trial

Placebo-Controlled Study of Uridine for Adolescent Bipolar Depression: a Magnetic Resonance Spectroscopy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 13 Years – 21 Years
• Healthy volunteers: Accepted

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.

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 addition to treatment with the investigational drug versus placebo, the study includes a translational neuroimaging component: magnetic resonance spectroscopy (1H-MRS) brain scans are performed at baseline, and then repeated following 6 weeks of treatment with uridine or placebo. The scans do not use radiation, and are performed on a 3 Tesla MRI system that is approved for clinical use. The scans allow researchers to measure the concentrations of several chemicals in the brain that are believed to be involved in bipolar disorder and depression. The primary hypothesis is that uridine treatment will be associated with a significant decrease in GLX (i.e. glutamate + glutamine) levels, compared to placebo, in a part of the brain known as the anterior cingulate cortex. The secondary hypothesis is that decreased depressive symptoms measured with the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery-Asberg Depression Rating Scale (MADRS) will be correlated with reductions in GLX. All participants who complete the initial 6-week protocol, including two brain scans, will be offered 6 months of open-label treatment with uridine.

Conditions

• Bipolar Disorder
• Bipolar Depression
• Manic Depression

Interventions

Type	Name	Description
DRUG	Uridine	Uridine is the active treatment in this clinical trial.
DRUG	Placebo	Pill placebo is the inactive treatment comparator in this clinical trial.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-03-06
• Last updated: 2018-03-12
• Results posted: 2018-03-12

Locations

1 site across 1 country: United States