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Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02456454
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert Kowatch, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 24, 2015
First Posted Date  ICMJE May 28, 2015
Last Update Posted Date December 12, 2018
Study Start Date  ICMJE January 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Young Mania Rating Scale [ Time Frame: 6 weeks ]
Young Mania Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02456454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2018)
Clinical Global Improvement Scale [ Time Frame: 6 weeks ]
Clinical Global Improvement Scale
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Clinical Global Improvement Scale [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Official Title  ICMJE Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Brief Summary Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
Detailed Description The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: Risperidone
    Liquid risperidone
    Other Name: Risperdal
  • Drug: Valproic Acid
    Liquid valproic acid
    Other Name: Valproate
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Risperidone
    Risperidone, PO 0.25-2 mg/day
    Intervention: Drug: Risperidone
  • Experimental: Valproic
    Valproic Acid PO to achieve plasma levels of 85-100
    Intervention: Drug: Valproic Acid
  • Placebo Comparator: Placebo
    Liquid placebo PO matched for color and taste.
    Intervention: Drug: Placebo
Publications * Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2014.0166.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Subjects were male or female outpatient subjects,
  • 3.0 - 7 years 11 months of age
  • Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
  • with a score > 20 on the Young Mania Rating Scale (YMRS.

Exclusion Criteria

  • clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;
  • neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:

    • CBC with differential,
    • electrolytes,
    • BUN,
    • creatinine,
    • hepatic transaminases,
    • urinalysis,
    • thyroid indices (T3, Total T4, Free T4, TSH) and
    • EKG
  • mania due to a general medical condition or substance-induced mania
  • mental retardation (IQ <70),
  • evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
  • Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02456454
Other Study ID Numbers  ICMJE CHMC#03-12-26
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert Kowatch, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Stanley Medical Research Institute
Investigators  ICMJE
Principal Investigator: Robert A Kowatch, MD, PhD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP