Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076115
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-01-14
Brief Title:
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children REACH A Double-Blind Randomized Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder
Status:
COMPLETED
Status Verified Date:
2010-04
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 determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder manic or mixed type in children and adolescents aged 10 to 17 years
Detailed Description:
Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode On enrollment subjects will be assigned to receive 1 of 3 treatments oral placebo tablets oral risperidone tablets 05 to 25 mg or oral risperidone tablets 3 to 6 mg which will be administered daily for 3 weeks Study medication will be increased to the target dosage during the first 7 days then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10 The maximum tolerated dose will be given for the last 12 days of the study Risperidone 05 to 25 mg or 3 to 6 mg doses or placebo given orally as 025 05 1 2 3 or 4 mg tablets or matching placebo each day for 3 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