Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034749
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2002-05-02
Brief Title:
The Efficacy 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 Adolescents With Schizophrenia a Comparison of Two Dose Ranges of Risperidone
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:
A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia
Detailed Description:
This is a clinical study of an investigational drug called risperidone in the treatment of schizophrenia in adolescents Initially children age 2 to 12 yrs and schizophreniform subjects were also allowed but excluded following protocol amendment
The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges according to the assigned study group
Initially the two dose range were 015-04 mgday and 15-4mgday but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 35mgday and maximum of 6mgday resp 035 and 06mgday in low dose treatment arm Risperidone lower dose 035-06 mgday subjects 50kg or 0007-0012 mgkgday subjects 50 kg as 01 mgmL oral solution or risperidone higher dose 35-6 mgday subjects 50 kg or 007-012 mgkgday subjects 50 kg as 1 mgmL oral solution for 8 weeks Daily dose can be given all at once or through 2 administrations in morning and evening the dose is increased based on efficacy and tolerability
The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges according to the assigned study group
Initially the two dose range were 015-04 mgday and 15-4mgday but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 35mgday and maximum of 6mgday resp 035 and 06mgday in low dose treatment arm Risperidone lower dose 035-06 mgday subjects 50kg or 0007-0012 mgkgday subjects 50 kg as 01 mgmL oral solution or risperidone higher dose 35-6 mgday subjects 50 kg or 007-012 mgkgday subjects 50 kg as 1 mgmL oral solution for 8 weeks Daily dose can be given all at once or through 2 administrations in morning and evening the dose is increased based on efficacy and tolerability
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