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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
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Douglas Kondo, MD, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Bipolar Depression Manic Depression Drug: Uridine Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Active Comparator: Uridine
Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.
Drug: Uridine
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.
Drug: Placebo
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.



Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria For Bipolar Disorder Participants:

  • 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.

Inclusion Criteria For Healthy Comparison Participants:

  • 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 not meet any DSM-IV criteria for a psychiatric illness or substance use disorder

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.

Information from the National Library of Medicine

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


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators
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Principal Investigator: Douglas Kondo, MD University of Utah

Additional Information:
Publications:
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Responsible Party: Douglas Kondo, MD, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01805440     History of Changes
Other Study ID Numbers: University of Utah
First Posted: March 6, 2013    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Informed Consent to publicly share individual participant data, e.g. MRI and MRS brain scans, was not obtained.

Keywords provided by Douglas Kondo, MD, University of Utah:
Adolescent
Bipolar Disorder
Bipolar Depression
Manic Depression
Neuroimaging
Magnetic Resonance Spectroscopy
Uridine
Pyrimidines

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders