Learning DisordersPhase 3NCT00254930
A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
A Phase 3 study testing risperidone in people with Learning Disorders and Child Behavior Disorders, run by Janssen-Cilag Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Learning Disorders, Child Behavior Disorders
- What is being tested?
- risperidone
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Prospective Trial of Risperdal (Risperidone) Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children
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.
Read the 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.
- Conditions
- Learning Disorders, Child Behavior Disorders
- Being tested
- risperidone
- Keywords
- learning disorder, children, behaviour disorder, risperidone
- Medical subject headings
- Learning Disabilities, Child Behavior Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startSep 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254930
- Sponsor's protocol ID
- CR005797
- Status last verified
- Mar 2010
- First submitted
- 15 Nov 2005
- Last updated
- 20 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Risperdal (Risperidone) Following Psychological Therapy for Challenging Behaviour in Learning Disabled Children
- ClinicalTrials.gov ID
- NCT00254930
- Acronym / sponsor ID
- CR005797
- Conditions
- Learning Disorders, Child Behavior Disorders
- Keywords
- learning disorder, children, behaviour disorder, risperidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Jun 2006 (actual)
- First posted
- 17 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risperidone | Drug | – |
Primary outcome
Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)
1 secondary outcome
Changes compared to baseline of Aberrant Behaviour Checklist (ABC) subclasses; hostility checklist; Clinical Global Impression (CGI) of severity; child quality of life rating scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
- Prospective trial of risperidone (Risperdal) following psychological therapy for challenging behaviour in learning disabled childrenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risperidone in people with Learning Disorders and Child Behavior Disorders, run by Janssen-Cilag Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2011; AzTrials last refreshed its copy on 31 Oct 2026.