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A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children

Primary Purpose

Learning Disorders, Child Behavior Disorders

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
risperidone
Sponsored by
Janssen-Cilag Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Learning Disorders focused on measuring learning disorder, children, behaviour disorder, risperidone

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV Axis II diagnosis of mental retardation behavioural and family therapy tried for 6 months but has failed in school, at least part time score of >=8 on hostility scale subject is otherwise healthy Exclusion Criteria: Patients with a seizure disorder requiring repeated change of medication extrapyramidal symptoms not well controlled by medication abnormal and clinically significant electrocardiogram (ECG) changes history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state) known hypersensitivity to antipsychotic medications, including risperidone.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)

    Secondary Outcome Measures

    Changes compared to baseline of Aberrant Behaviour Checklist (ABC) subclasses; hostility checklist; Clinical Global Impression (CGI) of severity; child quality of life rating scale

    Full Information

    First Posted
    November 15, 2005
    Last Updated
    May 18, 2011
    Sponsor
    Janssen-Cilag Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00254930
    Brief Title
    A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
    Official Title
    Prospective Trial of Risperdal (Risperidone) Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen-Cilag Ltd.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess whether risperidone (an antipsychotic medication) is safe and effective in treating behaviour disorder in learning disabled children, which does not improve with psychological therapy.
    Detailed Description
    There is a high incidence of behaviour disorder in people who are learning disabled. The purpose of this study is to assess whether risperidone is safe and effective in the treatment of learning disabled children diagnosed with behaviour disorder, which does not improve with psychological therapy. If the learning disability is very severe, or the behaviour disorder is very severe, such therapy is not appropriate and thus is not attempted; these patients are nevertheless eligible to participate in the study. At the beginning of treatment, the dose of risperidone is titrated, by gradual increase from 0.25 mg/day up to a maximum of 4 mg/day, based on therapeutic response, with decreases allowed in case of adverse reactions. Patients will be assessed over six months. The primary measure of effectiveness is the change compared to baseline in the total score on the Aberrant Behaviour Checklist (ABC). The EPSS is used to monitor the appearance of extrapyramidal symptoms. Based on results from other studies and the differences observed as a result of treatment, the investigator and his team expect to be able to detect a statistically and clinically significant result if data are available for 15 evaluable patients. Twenty patients will be recruited, taking account of possible drop outs. 0.25 mg of risperidone per day, taken orally, up to a maximum daily dose of 4 mg/day, for a treatment period of 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Learning Disorders, Child Behavior Disorders
    Keywords
    learning disorder, children, behaviour disorder, risperidone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    risperidone
    Primary Outcome Measure Information:
    Title
    Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)
    Secondary Outcome Measure Information:
    Title
    Changes compared to baseline of Aberrant Behaviour Checklist (ABC) subclasses; hostility checklist; Clinical Global Impression (CGI) of severity; child quality of life rating scale

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: DSM-IV Axis II diagnosis of mental retardation behavioural and family therapy tried for 6 months but has failed in school, at least part time score of >=8 on hostility scale subject is otherwise healthy Exclusion Criteria: Patients with a seizure disorder requiring repeated change of medication extrapyramidal symptoms not well controlled by medication abnormal and clinically significant electrocardiogram (ECG) changes history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state) known hypersensitivity to antipsychotic medications, including risperidone.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Cilag Ltd. Clinical Trial
    Organizational Affiliation
    Janssen-Cilag Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=263&filename=CR005797_CSR.pdf
    Description
    Prospective trial of risperidone (Risperdal) following psychological therapy for challenging behaviour in learning disabled children

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    A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children

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