Background and objectives : Risperidone, a benzisoxazol derivative, is a novel antipsychotic agent which combines potent serotonin 5-HT2 and dopamine D2 receptor antagonism. In clinical trials with chronic schizophrenics, risperidone has an
overall
therapeutic activity comparable with that of haloperidol, but risperidone has greater effect on the negative symptoms and produce less extrapyramidal side effects than does haloperidol. An open comparative clinical trial was conducted to study
the
efficacy and safty of risperidone compared with haloperidol
@ES Subjects and methods:
@EN After two-week wash-out, 86 chronic schizophrenic patients(44 males, 42 females) were randomly assigned to one of two groups for eight weeks of treatment. The patient's psychopathology was assessed by means of the Positive and negative
Syndrome
Scale for Schizophrenia(PANSS) and the Clinical Global Impression(CGI). Safety assessments included the Extrapyramidal Symptom Rating Scale(ESRS), the UKU Side Effect Rating Scale, vital sings, body weight, electrocardiogram and laboratory
screening.
@ES Results:
@EN The results on the PANSS indicate that risperidone group was better scores than haloperidol group in PANSS total score, positive subscale and negative subscale score. CGI scores were similar results. Risperidone group was more than
haloperidol
group
in the number of patients where a clinical improvement at least20% reduction in basleline score. Risperidone caused less extrapyramidal symptoms in ESRS and more orthostatic dizziness and photosensitivity in UKU scale than haloperidol group. No
clinically significant changes of ECG and laboratory parameters were induced.
@ES Conclusions:
@EN This study has demonstrated that the combined serotonin 5-HT2 and dopamine D2 antagonist risperidone is more portent antipsychotics including negative symptoms than haloperidol(statistically significant). Risperidone causes less
extrapyramidal
symptoms than haloperidol. Similar tolerability was seen in both treatment group. the authors concludes that risperidone is safe, tolerable, and effective drug for the treatment of chronic schizophrenia.
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