A Phase 3 interventional study of risperidone in Learning Disorders and Child Behavior Disorders, sponsored by Janssen-Cilag Ltd.. Completed. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2011-05-20.
Sponsored by Janssen-Cilag Ltd. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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.
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.
270 studies on the registry are indexed under Learning Disabilities; 62 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 181 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)
Changes compared to baseline of Aberrant Behaviour Checklist (ABC) subclasses; hostility checklist; Clinical Global Impression (CGI) of severity; child quality of life rating scale
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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Risperidone