Relapse prevention in children and adolescents with aggressive behaviour problems treated with risperidone

Not Applicable

Completed

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

• Registration Number: ISRCTN95609637
• Lead Sponsor: Radboud University Nijmegen Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-16
• Study Completion: 2015-06-01
• Last Update Posted: 24 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients (male or female) must be at least 5 years of age, and not more than 17 years and 5 months of age at Visit 1
2. Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV CD (312.xx)
3. Patients must have an intelligence quotient (IQ) of > 85
4. Patients must score > 27 on the Nisonger Child Behavior Rating (CBR) Form, Oppositional Defiant Disorder (ODD)/Conduct Disorder (CD) Disruptive Behavior Composite (D-Total) at baseline (Visit 1 or 2)
5. Patients must have a body weight comprised between 5th and 95th percentile based on WHO Body Mass Index for age-sex specific charts, at study entry
6. Patients must be able to swallow the study drug
7. Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per protocol
8. If the patient is a female with child-bearing potential, she must test negative for pregnancy (based on a urine pregnancy test) at the time of enrollment and agree to use a reliable method of birth control
9. Laboratory results, including serum chemistries, hematology and urinalysis, show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) and there is no clinical information that, in the judgment of a physician, should preclude a patients participation at study entry
10. All patients must have an electrocardiogram (ECG) at Visit 1 or 2. Results must be available prior to dispensing drug at Visit 3. If an ECG shows any severe abnormality, the patient must be excluded from the study. Patients with other abnormalities may be included at the discretion of the investigator.

Exclusion Criteria

1. Has previously completed or withdrawn from this study or has been previously identified as being a non-responder or intolerant of risperidone
2. Has been treated within 14 days before Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry, or has participated in any investigational drug trial within six months prior to baseline (visit 1)
3. Has a current (within 6 months of the start of the study) or lifetime DSM-IV diagnosis of schizophrenia-related disorders, schizophrenia, bipolar disorder, major depressive disorder or a 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)
4. In the clinical judgment of the investigator, currently meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourettes Syndrome [comorbid Attention deficit hyperactivity disorder (ADHD) is permitted]
5. Starts any psychotropic medication, including health-food supplements that the investigator feels could have central nervous system activity (for example, St. John's Wort, melatonin), during the course of the study, or is taking any other excluded concomitant medication(s). (An ongoing long-term medication, e.g., to treat a comorbid disorder such as ADHD, is permitted as long as compound and dose are not changed throughout the course of the study)
6. Has a history of hypersensitivity to neuroleptics, of tardive dyskinesia, or neuroleptic malignant syndrome
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. Female patients who are pregnant or breastfeeding
10. Patients with a history of severe allergies to more than oneb class of medications or multiple adverse drug reactions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to test the hypothesis that, after at least 15 weeks of daily administration (4 for titration, 7 of relatively stable dose, 4 at fixed doses; Study Period II), risperidone given orally in a dose of 0.25 to 3.0 mg/d depending on body weight (eq. to approximately 0.01 to 0.04 mg/kg/d) is superior to placebo in preventing relapse of symptoms of CD, as assessed through an 11-week, double-blind discontinuation trial (Study Period III) of children and adolescents not developmentally delayed/mentally retarded, and measured by comparison with mean change from the double-blind baseline to endpoint on the Nisonger Child Behavior Rating Form (CBRF) - Typical IQ Version (Aman et al., 2008) using investigator-ratings based on all available information.