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Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Risperidone
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Mania, Manic, Depressive, Manic Depressive, Bipolar mania, risperidone, adolescents, children

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Current primary diagnosis of bipolar I disorder, mania or mixed type Aged between 10 and 17 years Young Mania Rating Scale score greater than or equal to 20 at screening and baseline Exclusion Criteria: Known or suspected history of substance dependence Significant risk for suicidal or violent behavior Received electroconvulsive treatment within 4 weeks of baseline Received a depot antipsychotic within 2 treatment cycle before baseline Is unable to swallow medication taken in the form of tablets Has a positive result for a urine drug screen done at baseline Known or suspected seizure disorder Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening Known or suspected history of hypersensitivity or intolerance to risperidone History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The change in the total YMRS score from baseline at the 3-week endpoint

    Secondary Outcome Measures

    Effects on secondary efficacy variables (YMRS response and onset of maintained response, Clinical Global Impression Scale - Bipolar Disorder [CGI-BP]), safety, tolerability, and pharmacokinetics.

    Full Information

    First Posted
    January 14, 2004
    Last Updated
    June 6, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00076115
    Brief Title
    Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
    Official Title
    Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.
    Detailed Description
    Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study. Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder
    Keywords
    Bipolar, Mania, Manic, Depressive, Manic Depressive, Bipolar mania, risperidone, adolescents, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone
    Primary Outcome Measure Information:
    Title
    The change in the total YMRS score from baseline at the 3-week endpoint
    Secondary Outcome Measure Information:
    Title
    Effects on secondary efficacy variables (YMRS response and onset of maintained response, Clinical Global Impression Scale - Bipolar Disorder [CGI-BP]), safety, tolerability, and pharmacokinetics.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Current primary diagnosis of bipolar I disorder, mania or mixed type Aged between 10 and 17 years Young Mania Rating Scale score greater than or equal to 20 at screening and baseline Exclusion Criteria: Known or suspected history of substance dependence Significant risk for suicidal or violent behavior Received electroconvulsive treatment within 4 weeks of baseline Received a depot antipsychotic within 2 treatment cycle before baseline Is unable to swallow medication taken in the form of tablets Has a positive result for a urine drug screen done at baseline Known or suspected seizure disorder Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening Known or suspected history of hypersensitivity or intolerance to risperidone History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=532&filename=CR003631_CSR.pdf
    Description
    Study to Determine the Effectivness of Risperidone in Bipolar Disorder in Children and Adolescents

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