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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
This study has been completed.
First Received: November 15, 2005   Last Updated: November 20, 2008   History of Changes
Sponsored by: Janssen-Cilag Ltd.
Information provided by: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT00254930
  Purpose

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.


Condition Intervention Phase
Child Behavior Disorders
Learning Disorders
Drug: risperidone
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Prospective Trial of Risperdal® (Risperidone) Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.:

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

Estimated Enrollment: 20
Study Start Date: September 2003
Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254930

Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR005797
Study First Received: November 15, 2005
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00254930     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Janssen-Cilag Ltd.:
learning disorder
risperidone
behaviour disorder
children

Study placed in the following topic categories:
Child Behavior Disorders
Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Learning Disorders
Antipsychotic Agents
Serotonin
Signs and Symptoms
Dopamine
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Dopamine Agents
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Neurobehavioral Manifestations
Child Behavior Disorders
Disease
Tranquilizing Agents
Nervous System Diseases
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Learning Disorders
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents
Communication Disorders

ClinicalTrials.gov processed this record on September 02, 2009