Clinical TrialID 4974

Uridine Adolescent Bipolar Depression Randomized Controlled Trial

NCT01805440

Bipolar Disorder|Bipolar Depression|Manic Depression

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Record Fields

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Clinical Trial Id
4974
Evidence Id
4974
Core Evidence Id
4974
Source Clinical Trial Id
4954
Herb2 Clinical Trial Id
HBCT004954
Nct Id
NCT01805440
Title
Uridine Adolescent Bipolar Depression Randomized Controlled Trial
Status
Completed
Phase
Study Result
Yes
Study Condition
Bipolar Disorder|Bipolar Depression|Manic Depression
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Intervention
DRUG: Uridine|DRUG: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Other
Gender
All
Age
Child, Adult
Enrollment
62
Outcome Measure
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)., 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., Baseline and 6 weeks|Change in Children's Depression Rating Scale-Revised (CDRS-R) Score., 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)., 6 weeks
Sponsor Collaborator
University of Utah|The Depressive and Bipolar Disorder Alternative Treatment Foundation
Funded By
OTHER
Location
University of Utah, Salt Lake City, Utah, 84108, United States
Other Id
University of Utah
Start Date
2013-08
Primary Completion Date
2015-12
Completion Date
2015-12
First Posted
2013-03-06
Results First Posted
2018-03-12
Last Update Posted
2018-03-12
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01805440
Title Cn
Title En
Uridine Adolescent Bipolar Depression Randomized Controlled Trial
Bilingual Status
semi_complete