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.
Information provided by:
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
First received: November 15, 2005
Last updated: May 18, 2011
Last verified: March 2010
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
Learning Disorders
Child Behavior Disorders
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Enrollment: 19
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.

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00254930

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00254930     History of Changes
Other Study ID Numbers: CR005797 
Study First Received: November 15, 2005
Last Updated: May 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on May 01, 2016