Uridine Adolescent Bipolar Depression Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01805440|
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Bipolar Depression Manic Depression||Drug: Uridine Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled Study of Uridine for Adolescent Bipolar Depression: a Magnetic Resonance Spectroscopy Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Uridine
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Uridine is the active treatment in this clinical trial.
Placebo Comparator: Placebo
Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.
Pill placebo is the inactive treatment comparator in this clinical trial.
Other Name: Pill Placebo
No Intervention: Healthy Comparison
Subjects are not randomized, and do not receive any treatment intervention.
- Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS). [ Time Frame: Baseline and 6 weeks ]Magnetic Resonance Spectroscopy is a safe, non-invasive method for measuring brain chemicals thought to be involved in mood disorders, such as GLX (glutamate + glutamine). Previous research indicates that adolescents with bipolar depression have elevated Glx concentrations, compared with controls. The measurement of Glx with 1H-MRS has the potential to identify translational biomarkers of juvenile BD pathophysiology and treatment response.
- Change in Children's Depression Rating Scale-Revised (CDRS-R) Score. [ Time Frame: 6 weeks ]The CDRS-R is a brief rating scale based on a semi-structured interview with the participant (and/or their parent or guardian). The scale can be administered and scored in under 30 minutes. The CDRS-R gives you a single summary score -- with an interpretation of, and clinical recommendations for, six different score ranges. Total possible scores range from 17 to 113, with higher scores indicating more depressive symptoms reported by the participant (and/or their parent or guardian).
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 weeks ]The Columbia-Suicide Severity Rating Scale (C-SSRS) is used to measure suicidal thoughts and behaviors in Investigational New Drug (IND) studies. The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805440
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Douglas Kondo, MD||University of Utah|