Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250354
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-11-04
Brief Title:
A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild Moderate or Borderline Mental Retardation
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
The Safety And Efficacy Of Risperidone Versus Placebo In Conduct Disorder In Mild Moderate And Borderline Mentally Retarded Children Aged 5 To 12 Years
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to assess the safety and effectiveness of oral risperidone an antipsychotic medication in the treatment of conduct disorder and other disruptive behavior disorders in children ages 5 to 12 with mild moderate or borderline mental retardation
Detailed Description:
Conduct and psychiatric disorders are found among a higher proportion of people with mental retardation than among people who are not mentally retarded Among many different treatment approaches to conduct disorder are drug therapy behavioral treatment psychotherapy cognitive and social learning Studies have suggested that neuroleptic drugs such as risperidone may be beneficial in treating conduct disorder in mental retardation This is a randomized double-blind study to evaluate the effectiveness of risperidone compared with placebo in the treatment of children 5 to 12 years of age with mild moderate or borderline mental retardation who display destructive behaviors The study has 2 phases a run-in phase of 1 week and a treatment phase of 6 weeks Patients receive placebo to be taken orally once a day during the first week run-in On the basis of scores on the Nisonger Child Behavior Rating Form N-CBRF after the first week patients either continue in the double-blind treatment phase or discontinue the study During the treatment phase patients receive risperidone oral solution once daily at a starting dose of 001 mgkg body weight increasing gradually at the investigators discretion up to 006 mgkg maximum or placebo for 6 weeks A parent or caregiver evaluates the childs behavior and symptoms at scheduled office visits during the course of treatment The primary measure of efficacy is the change from baseline to the end of treatment in the Conduct Problem subscale of the N-CBRF Other efficacy assessments include the changes in the Aberrant Behavior Checklist ABC Behavioral Problems Inventory BPI and the Clinical Global Impression CGI a rating system used to evaluate the overall and severity of clinical change Safety assessments include the incidence of adverse events throughout the study weekly measurement of vital signs pulse temperature blood pressure and evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale ESRS and clinical laboratory tests hematology biochemistry urinalysis before study initiation and at end of treatment The study hypothesis is that risperidone will be well tolerated and effective for the treatment of conduct disorder in children aged 5 to 12 years with mild moderate or borderline mental retardation Risperidone oral solution 10 mgmL once daily Days 1 and 2 at a dose of 001 mgkg body weight Day 3 at a dose of 002 mgkg and increasing gradually up to 006 mgkg maximum daily through 6 weeks Dose may be increased or decreased at investigators discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None