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

NCT00254930 | Completed Phase 3

• 1 other identifier: CR005797
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Learning Disorders; Child Behavior Disorders

Keywords

learning disorder; children; behaviour disorder; risperidone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Related Links

• Prospective trial of risperidone (Risperdal) following psychological therapy for challenging behaviour in learning disabled children

MeSH Terms

Conditions

Learning Disabilities; Child Behavior Disorders; Mental Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: September 1, 2003
• Study Completion: June 1, 2006
• Last Updated: May 20, 2011

Record last verified: 2010-03