Risperidone design

In another study, 118 children with IQs ranging from 35 to 84 who demonstrated conduct disorder were randomized to risperidone (at a mean dose of 1.23 mg/day) versus placebo in a double-blind design (96). In comparison with placebo, risperidone produced a statistically significant reduction in insecure/anxious behavior, hyperactivity, self-injurious/stereotyped behavior, irritability, and aggressive/destructive behavior, as well as an increase in adaptive social behavior. The latter is important because it shows that the changes are not due to sedation, although more somnolence was apparent with risperidone. 

A similar design was used in 249 patients with schizoaffective disorder who received injectable risperidone for 6 months (initial dose 25 mg in 82% of patients, end-point doses ranging from 25 mg in 49% of patients to 75 mg in one) oral risperidone supplementation was needed in 19% (mean modal dose 3 mg/day) (228). Three patients died during the study with heart attack, stroke, and gastrointestinal bleeding other important adverse events were increases in body weight and body mass index (mean increases 1.4 kg and 0.5 kg/m2), sexual dysfunction (4%), and new-onset diabetes mellitus (0.4%). 

A series related to risperidone, which was not designed to incorporate 5-HT antagonist activity, resulted in tiaspirone (133).This analog has a D2/5-HT2 ratio of 21, similar to that found for risperidone. The behavioral profile of tioperone was closer to clozapine... 

One of the newest strategies for the design of additional atypical antipsychotic drugs is to combine D -receptor blocking actions in the same molecule. Risperidone... 

Comparative studies The SCoP study was a prospective, randomized, partially blinded, active-controlled, multinational trial, designed to assess the safety of sertindole in the treatment of schizophrenia under normal conditions of use risperidone was the comparator. Results are now emerging. For instance, sertindole did not increase allcause mortality, but cardiac mortality was higher and suicide attempts possibly lower with sertindole [147. The study comprised 9858 selected patients with schizophrenia, and after 14147 person-years the major findings were (i) no statistically significant difference between sertindole ( = 4905) and risperidone (n = 4904) in the two co-primary outcomes, i.e. all-cause mortality (sertindole 64 deaths, risperidone 61 deaths HR=1.12 90% Cl = 0.83, 1.5) and cardiac events... 

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