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Sponsored by: |
Janssen-Cilag Ltd. |
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Information provided by: | Janssen-Cilag Ltd. |
ClinicalTrials.gov Identifier: | NCT00254930 |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | September 2003 |
Study Completion Date: | June 2006 |
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:
Exclusion Criteria:
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 |
learning disorder risperidone behaviour disorder children |
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 |
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 |