Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088075
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-07-19
Brief Title:
Investigate Risperidone for the Treatment of Schizophrenia in Adolescents
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Clinical Study of the Efficacy and Safety of Risperidone for the Treatment of Schizophrenia in Adolescents
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:
A clinical study to evaluate the efficacy safety and tolerability of two dose ranges of risperidone 1 to 3 mgday and 4 to 6 mgday versus placebo an inactive substance like a sugar pill in adolescents aged 13 to 17 years with schizophrenia ie abnormal behavior and thoughts The study duration is about 6 to 7 weeks
Detailed Description:
Subjects will be aged 13 to 17 years with a diagnosis of schizophrenia On enrollment subjects will be assigned to receive 1 of 3 treatments oral placebo tablets oral risperidone tablets 1 to 3 mg or oral risperidone tablets 4 to 6 mg which will be administered daily for 6 weeks Study medication will be increased to within the target dosage range during the first 7 days and then further increased until the maximum tolerated dose is achieved by day 14 The maximum tolerated dose will be maintained for the last 4 weeks of the study unless dose adjustments are agreed with the Sponsor Risperidone 1 to 3 mg or 4 to 6 mg or placebo given orally as 05 1 2 3 or 4 g tablets or matching placebo each day for 6 weeks
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