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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Risperidone
Valproic Acid
Placebo
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Risperidone

    Valproic

    Placebo

    Arm Description

    Risperidone, PO 0.25-2 mg/day

    Valproic Acid PO to achieve plasma levels of 85-100

    Liquid placebo PO matched for color and taste.

    Outcomes

    Primary Outcome Measures

    Young Mania Rating Scale
    Young Mania Rating Scale

    Secondary Outcome Measures

    Clinical Global Improvement Scale
    Clinical Global Improvement Scale

    Full Information

    First Posted
    April 24, 2015
    Last Updated
    December 10, 2018
    Sponsor
    Nationwide Children's Hospital
    Collaborators
    Stanley Medical Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02456454
    Brief Title
    Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
    Official Title
    Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nationwide Children's Hospital
    Collaborators
    Stanley Medical Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Risperidone
    Arm Type
    Experimental
    Arm Description
    Risperidone, PO 0.25-2 mg/day
    Arm Title
    Valproic
    Arm Type
    Experimental
    Arm Description
    Valproic Acid PO to achieve plasma levels of 85-100
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Liquid placebo PO matched for color and taste.
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone
    Other Intervention Name(s)
    Risperdal
    Intervention Description
    Liquid risperidone
    Intervention Type
    Drug
    Intervention Name(s)
    Valproic Acid
    Other Intervention Name(s)
    Valproate
    Intervention Description
    Liquid valproic acid
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Young Mania Rating Scale
    Description
    Young Mania Rating Scale
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Clinical Global Improvement Scale
    Description
    Clinical Global Improvement Scale
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert A Kowatch, MD, PhD
    Organizational Affiliation
    Nationwide Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25978742
    Citation
    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.
    Results Reference
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    Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

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