Uridine Adolescent Bipolar Depression Randomized Controlled Trial
This trial is active, not recruiting.
|Conditions||bipolar disorder, bipolar depression, manic depression|
|Sponsor||University of Utah|
|Collaborator||The Depressive and Bipolar Disorder Alternative Treatment Foundation|
|Start date||August 2013|
|End date||December 2015|
|Trial size||40 participants|
|Trial identifier||NCT01805440, University of Utah|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in GLX (glutamate + glutamine) in the Anterior Cingulate Cortex of the brain, as measured with Proton-1 Magnetic Resonance Spectroscopy (1H-MRS).
time frame: 6 weeks
Change in Children's Depression Rating Scale-Revised (CDRS-R) score.
time frame: 6 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: 6 weeks
Male or female participants from 13 years up to 21 years old.
Inclusion Criteria: - Participants under 18 years of age must be able to provide assent, and have the permission of a parent or guardian. Participants 18 years of age or older must be able to provide informed consent. - Participants must be between the ages of 13 and 21 years. - Participants must meet DSM criteria for Bipolar Disorder (Type I, II, or NOS), with current mood state depressed for at least 2 weeks. - Participants must have a current Children's Depression Rating Scale-Revised (CDRS-R) score of 45 or greater, and/or a Montgomery/Asberg Depression Rating Scale (MADRS) score of 25 or greater. Exclusion Criteria: - Participants must not meet DSM criteria for a primary psychotic disorder, a developmental disorder or substance use disorder. - Participants must not be at high risk for suicidal or homicidal actions. - Participants must not be pregnant or breastfeeding. - Participants must not have a contraindication to magnetic resonance imaging (e.g. ferromagnetic implant, or claustrophobic anxiety). - Incarcerated persons are excluded, because this study is not approved for Research Involving Prisoners.
|Official title||Placebo-Controlled Study of Uridine for Adolescent Bipolar Depression: a Magnetic Resonance Spectroscopy Study|
|Principal investigator||Douglas Kondo, MD|
|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.|
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