Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246285
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-28
Brief Title:
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Efficacy And Safety Of Risperidone In The Treatment Of Adolescents With Schizophrenia A Six-Month Open-Label Study
Status:
COMPLETED
Status Verified Date:
2010-03
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 risperidone an antipsychotic medication in adolescents with schizophrenia over 6 months of treatment
Detailed Description:
Although the safety and effectiveness of antipsychotic medications is well-established in adults with schizophrenia these drugs have not been examined rigorously in adolescents with this disorder Preliminary experience suggests that risperidone may hold promise for the treatment of these younger subjects This is an open-label multicenter trial of risperidone formulated as an oral solution and tablets in the treatment of adolescents with schizophrenia It is an open-label 6-month extension of two previous double-blind studies that assessed the safety and effectiveness of risperidone in the treatment of schizophrenia in an adolescent population Patients may also enroll directly in this open-label trial During the first week of the study patients will receive increasing doses of risperidone to reach an optimal daily dose 2 to 6 mgday which will be maintained throughout the 6 months of the study Assessments of effectiveness include the Positive and Negative Syndrome Scale for Schizophrenia PANSS a scale measuring the symptoms of schizophrenia the Clinical Global Impression-Severity of Illness subscale CGI-Severity a scale measuring the severity of illness the Clinical Global Impression-Improvement subscale CGI-Improvement a scale measuring clinical improvement and the Childrens Global Assessment Scale Safety evaluations include the incidence of adverse events throughout the study clinical laboratory tests hematology biochemistry and urinalysis vital signs blood pressure pulse and temperature weight and electrocardiogram ECG recordings at specified intervals The study hypothesis is that risperidone with be effective in the treatment of adolescents with schizophrenia and well tolerated Risperidone oral solution 1 mgml once daily dose increasing from 001 mgkg body weight Day 1 to a range from 2 to 6 mgday for 6 months Oral tablets 05 1 2 3 and 4 mg once daily dose increasing from 05 mg Day 1 to a range of 2 to 6 mgday for 6 months
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