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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254930
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : May 20, 2011
Information provided by:
Janssen-Cilag Ltd.

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.

Condition or disease Intervention/treatment Phase
Learning Disorders Child Behavior Disorders Drug: risperidone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Trial of Risperdal (Risperidone) Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children
Study Start Date : September 2003
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Primary Outcome Measures :
  1. Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254930

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

Additional Information: Identifier: NCT00254930     History of Changes
Other Study ID Numbers: CR005797
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: March 2010

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

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