A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Risperidone for the Treatment of Schizophrenia in Adolescents
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 160
- Primary Endpoint
- Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
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 0.5, 1, 2, 3, or 4 ,g tablets (or matching placebo) each day for 6 weeks.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint
Secondary Outcomes
- Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety and tolerability.