Uridine Adolescent Bipolar Depression Randomized Controlled Trial

NCT01805440 | Completed Results DMC

• 1 other identifier: University of Utah
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Bipolar Depression; Manic Depression

Keywords

Adolescent; Bipolar Disorder; Bipolar Depression; Manic Depression; Neuroimaging; Magnetic Resonance Spectroscopy; Uridine; Pyrimidines

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  6 weeks

Study Arms (3)

Uridine

ACTIVE COMPARATOR

Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.

Drug: Uridine

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks.

Drug: Placebo

Healthy Comparison

NO INTERVENTION

Subjects are not randomized, and do not receive any treatment intervention.

Interventions

Uridine DRUG

Uridine is the active treatment in this clinical trial.

Uridine

Placebo DRUG

Pill placebo is the inactive treatment comparator in this clinical trial.

Also known as: Pill Placebo

Placebo

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Kondo DG, Sung YH, Hellem TL, Delmastro KK, Jeong EK, Kim N, Shi X, Renshaw PF. Open-label uridine for treatment of depressed adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):171-5. doi: 10.1089/cap.2010.0054. Epub 2011 Apr 12.

  PMID: 21486171 BACKGROUND

Related Links

• Free downloadable full-text article

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Uridine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Limited sample size and small percentage of underrepresented racial/ethnic minority participants.

Results Point of Contact

• Title: Douglas Kondo, MD
• Organization: Department of Psychiatry

doug.kondo@hsc.utah.edu

801-583-2500

Study Officials

• Douglas Kondo, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)