Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266552
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-12-16
Brief Title:
A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children 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 and Other Disruptive Behavior Disorders 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 effectiveness and safety of an oral solution of risperidone an antipsychotic medication versus placebo in the treatment of conduct disorder in children 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 the many different treatment approaches to conduct disorder are drug therapy behavioral treatment psychotherapy and training for cognitive and social skills 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 placebo-controlled study to evaluate the effectiveness of risperidone 002 to 006 mgkgday compared with placebo in the treatment of children 5 to 12 years of age with mild moderate or borderline mental retardation and who display destructive behaviors The study has two 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 and the Vineland Adaptive Behavior Scale after the first week patients either continue in the double-blind treatment phase or discontinue the study During the treatment phase patients receive an oral solution of risperidone increasing gradually to a maximum dose of 006 mgkg or placebo to be taken once daily 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 effectiveness is the change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form N-CBRF at end of treatment compared with baseline Additional assessments of effectiveness include the Aberrant Behavior Checklist ABC the Behavioral Problems Inventory BPI and the Clinical Global Impression CGI 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 performed both before study initiation and at the end of treatment The study hypothesis is that risperidone is 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 1 mgmL or placebo oral solution once daily on Days 1 and 2 at dose of 001 mgkg body weight Dose is 002 mgkg on Day 3 increasing gradually to 006 mgkg maximum once daily through 6 weeks Dosage 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