Investigate Risperidone for the Treatment of Schizophrenia in Adolescents
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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