Investigate Risperidone for the Treatment of Schizophrenia in Adolescents

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior and thoughts). The study duration is about 6 to 7 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• A responsible person must be available to accompany the subject to the site at each visit

• patient must meet the DSM-IV criteria for schizophrenia

Exclusion Criteria:

• Patients with mild, moderate or severe mental retardation

• patients with a known or suspected history of substance dependence

• subjects weighing <35kg

• subjects who cannot swallow oral tablets