NCT00034749

The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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 0.15-0.4 mg/day and 1.5-4mg/day but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm) Risperidone lower dose (0.35-0.6 mg/day \[subjects \>=50kg\] or 0.007-0.012 mg/kg/day \[subjects \<50 kg\]) as 0.1 mg/mL oral solution or risperidone higher dose (3.5-6 mg/day \[subjects \>=50 kg\] or 0.07-0.12 mg/kg/day \[subjects \<50 kg\]) as 1 mg/mL 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone

Timeline

• Start date: 2001-04-01
• Completion: 2006-03-01
• First posted: 2002-05-03
• Last updated: 2011-06-08