A study to investigate efficacy, safety and tolerability of a medicin (risperidone) in treatment of aggression in children and adolescents.
- Conditions
- Conduct DisorderChildrenAdolescentsAggressionRisperidoneEfficacySafetyTolerabilityAgressie KinderenAdolescentenRisperidonMedicatieEffectiviteitVeiligheid
- Registration Number
- NL-OMON21876
- Lead Sponsor
- Prof J.K. Buitelaar, Radboud University Medical Centre, Nijmegen, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 264
Inclusion Criteria
Patients are eligible to be included in the study only if they meet all of the inclusion criteria below:
1. Male or female patients aged 5.0 - <17.0 years at Visit 1;
Exclusion Criteria
A patient will be excluded from the study if he or she meets any exclusion criteria described below, according to the assessment of the investigator:
1. Is immediate family of investigator site personnel directly affiliated with this study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rating scales used in this study are accepted methods for assessing the respective variables for which they were developed. It is proposed that treatment with risperidone may reduce disruptive behaviour so that patients suffering from CD can function better and engage more effectively in their external environment.<br /><br>The use of the ODD/CD (D-Total) composite of the Nisonger CBRF-TIQ ( Aman et al., 2008) as the primary outcome measure will assess the effect of risperidone treatment on disruptive behaviour.
- Secondary Outcome Measures
Name Time Method