Oral Uridine for Treatment of Bipolar Depression in Adolescents

NCT00841269 | Completed Phase 2 Results DMC

• 2 other identifiers: 284555R01MH058681-06
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if the investigational medication uridine reduces depression symptoms in adolescents with bipolar disorder. Uridine is a naturally occurring chemical that is made by the human liver. Uridine is part of a family of compounds called pyrimidines, and is normally involved in many of the body's processes such as the use of energy by cells. Uridine is considered experimental, because it has not been approved by the U.S. Food and Drug Administration (FDA) to treat bipolar depression in adolescents. The study will use standard methods of assessing adolescent's mood, such as rating scales and questionnaires. In addition, the study will use Magnetic Resonance Imaging Spectroscopy (MRI/MRS) brain scans to see if levels of certain chemicals in the brain change when adolescents are treated with uridine. These scans use a magnet to create images of the brain, and do not expose patients to radiation.

Conditions

Bipolar Disorder

Keywords

Bipolar Manic Depression

Outcome Measures

Primary Outcomes (2)

• Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment

  The CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.

  6 weeks

• The Primary Neuroimaging Outcome Will be Changes in Beta-NTP to TP (Total Phosphorus) Ratio in the Anterior Cingulate.

  6 weeks

Secondary Outcomes (1)

• A Secondary Outcome Measure Includes a Change in Young Mania Rating Scale (YMRS) Score

  6 weeks

Study Arms (2)

Uridine

EXPERIMENTAL

Uridine 500 mg by mouth twice daily for 6 weeks

Drug: Uridine

Healthy Comparison

NO INTERVENTION

Healthy comparison participants were seen for baseline and week 6 MRI scans. No treatment was administered to participants enrolled as healthy comparisons.

Interventions

Uridine DRUG

Uridine 500 mg by mouth twice per day for 6 weeks

Uridine

Eligibility Criteria

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

You may qualify if:

• Participants must meet DSM-IV-TR (American Psychiatric Association, 2000) criteria for Bipolar Disorder Type I, Type II, or Not Otherwise Specified (NOS) with current mood state depressed for \> 2 weeks
• Participants must be between the age of 13 and 18 years
• Participants who enter the study on psychotropic medications must be on a regimen that has been stable for \> 2 weeks at the time of study entry
• Participants must be able to give informed consent or assent, and parent(s)/guardian(s) must be able to give informed permission for study participation

You may not qualify if:

• Adolescents with an unstable co-morbid medical, neurological, or psychiatric disorder
• Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice contraception during the study
• Participants with high risk of suicidal behaviors, homicidal behaviors, or self-harm
• Participants who in the opinion of the investigator are unlikely to be able to comply with the study protocol
• Participants who meet DSM-IV-TR criteria for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence
• Participants for whom the MRI/MRS scans are contraindicated, such as children with ferromagnetic implants or claustrophobia
• Participants whose mood state is manic
• Documented or suspected history of mental retardation (IQ\<70)
• Positive urine drug screen for cocaine or amphetamines
• Known hypersensitivity to uridine
• Selection of Healthy Volunteers:
• Participants must be between the ages of 13 and 18 years
• Participants must not meet DSM-IV-TR diagnostic criteria for a mental disorder or substance abuse
• Participants must be able to give informed consent or assent and parents/guardians must be able to give informed permission for participation
• Clinically significant medical, neurological, psychiatric or substance abuse disorder

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Utah School of Medicine

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 RESULT

Related Links

• UtahBrain.org

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: Dr. Douglas Kondo
• Organization: University of Utah

doug.kondo@hsc.utah.edu

(801) 587-1549

Study Officials

• Douglas G Kondo, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 26, 2018
• Results First Posted: January 8, 2015

Record last verified: 2018-02

Locations

US (1)