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.
Sponsor:
Information provided by:
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT00254930
First received: November 15, 2005
Last updated: May 18, 2011
Last verified: March 2010
  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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
children
behaviour disorder
risperidone

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

ClinicalTrials.gov processed this record on July 29, 2014