Risperidone in children and adolescents with aggressive behaviour

Not Applicable

Completed

• Conditions: Conduct disorder / Oppositional Defiant Disorder; Mental and Behavioural Disorders; Conduct disorders

• Registration Number: ISRCTN95429815
• Lead Sponsor: Radboud University Nijmegen Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-16
• Study Completion: 2015-04-01
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. This study will include male and female inpatients or outpatients
2. Aged between 5 years and 17 years and 9 months
3. Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV-TR Conduct Disorder(s)
4. Patients must have an IQ of > 85
5. If a female of child-bearing potential, patients must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control
6. Patients must have a body weight of at least 20 kg at study entry
7. Patients must be able to swallow study drug
8. Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws

Exclusion Criteria

1. Has been treated with a drug within 14 days before Visit 1 that has not received regulatory approval for any indication at the time of study entry
2. Has participated in any investigational drug trial within six months prior to baseline
3. Has previously completed or withdrawn from this study or any other study investigating risperidone or has previously been identified as being a nonresponder or intolerant of risperidone
4. Has a current (within 6 months of the start of the study) or lifetime DSM-IV-TR diagnosis of schizophrenia-related disorders, schizophrenia, bipolar disorder, major depressive disorder, or current substance dependence disorder (given the nature of the study population substance misuse or abuse is not exlusionary), pervasive developmental disorder (autistic disorder or Asperger disorder).
5. In the clinical judgment of the investigator, currently meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourette?s Syndrome
6. Starts any psychotropic medication, including health-food supplements that the investigator feels could have central nervous system activity
7. Has any acute or unstable medical condition, physiological condition, clinically significant laboratory, or ECG results that, in the opinion of the investigator, would compromise participation in the study.
8. Has a known or suspected seizure disorder
9. Has a history of neuroleptic malignant syndrome (NMS) or of tardive dyskinesia
10. Has a history of hypersensitivity to neuroleptics
11. Is pregnant or nursing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Nisonger Child Behavior Rating Form (CBRF)<br> 2. Typical IQ Version-ODD/CD disruptive behavior (DBD)<br> 3. Composite Total score (Aman et al., 2008) using investigator-ratings based on all available information<br>