Risperdal Clinical Pharmacology

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Risperdal - Clinical Pharmacology [Risperidone]

( 1) In a 6-week, placebo-controlled trial ( n= 160) nvolving titration of RISPERDAL Ž in doses up to 10 mg/ day ( BID schedule) , RISPERDAL Ž was generally superior to placebo on the BPRS total score, on the BPRS psychosis cluster, and marginally superior to placebo on the SANS.

( 2) In an 8-week, placebo-controlled trial ( n= 513) nvolving 4 fixed doses of RISPERDAL Ž ( 2, 6, 10, and 16 mg/ day, on a BID schedule) , all 4 RISPERDAL Ž groups were generally superior to placebo on the BPRS total score, BPRS psychosis cluster, and CGI severity score; the 3 highest RISPERDAL Ž dose groups were generally superior to placebo on the PANSS negative subscale. The most consistently positive responses on all measures were seen for the 6 mg dose group, and there was no suggestion of increased benefit from larger doses.

( 3) In an 8-week, dose comparison trial ( n= 1356) nvolving 5 fixed doses of RISPERDAL Ž ( 1, 4, 8, 12, and 16 mg/ day, on a BID schedule) , the four highest RISPERDAL Ž dose groups were generally superior to the 1 mg RISPERDAL Ž dose group on BPRS total score, BPRS psychosis cluster, and CGI severity score. None of the dose groups were superior to the 1 mg group on the PANSS negative subscale. The most consistently positive responses were seen for the 4 mg dose group.

( 4) In a 4-week, placebo-controlled dose comparison trial ( n= 246) nvolving 2 fixed doses of RISPERDAL Ž ( 4 and 8 mg/ day on a QD schedule) , both RISPERDAL Ž dose groups were generally superior to placebo on several PANSS measures, including a response measure ( > 20% reduction in PANSS total score) , PANSS total score, and the BPRS psychosis cluster ( derived from PANSS) . The results were generally stronger for the 8 mg than for the 4 mg dose group.

Long-Term Efficacy

In a longer-term trial, 365 adult outpatients predominantly meeting DSM-IV criteria for schizophrenia and who had been clinically stable for at least 4 weeks on an antipsychotic medication were randomized to RISPERDAL Ž ( 2-8 mg/ day) or to an active comparator, for 1 to 2 years of observation for relapse. Patients receiving RISPERDAL Ž experienced a significantly longer time to relapse over this time period compared to those receiving the active comparator.