Risperidone versus haloperidol in psychotic patients with disturbing neuroleptic-induced extrapyramidal symptoms: a double-blind, multi-center trial.

BACKGROUND: A randomized, double-blind, multi-center trial was started to compare the severity of extrapyramidal symptoms (EPS) during risperidone and haloperidol treatment in schizophrenic patients who had disturbing EPS during their previous neuroleptic treatment. Additional objectives of this trial were comparing the antipsychotic effectiveness of the two treatments and the use of antiparkinsonian medication. METHODS: Effects of flexible doses of risperidone and haloperidol were compared in 77 psychotic patients (83% with chronic schizophrenia) with disturbing neuroleptic-induced EPS (risperidone 40 patients, haloperidol 37). The trial was completed by 47 patients: 25 in the risperidone group (12 women, 13 men), and 22 in the haloperidol group (10 women, 12 men). RESULTS: An adequate antipsychotic effect was obtained in most patients by both treatments. The primary aim of this trial was comparing parkinsonism measured with the extrapyramidal syndrome rating scale (ESRS) during treatment with risperidone and haloperidol. Two primary parameters were selected: the change from baseline to the worst score during treatment of ESRS II (parkinsonism) and ESRS VI (clinical global impression of severity of parkinsonism). The CGI of severity of parkinsonism was better with risperidone (P=0.025), while the parkinsonism total score tended to be better with risperidone (P<0. 10). Before the double-blind treatment, 34 (of the 77) had used antiparkinson medication (risperidone 18, haloperidol 16). During the double-blind treatment phase, 21 patients had used antiparkinson medication (risperidone 11, haloperidol 10). The larger reduction of parkinsonism in the risperidone group was not due to a difference in the use of anti-parkinsonian medication. CONCLUSIONS: In this group of schizophrenic patients with disturbing EPS during previous neuroleptic treatment, a stronger reduction of parkinsonism was observed with risperidone than with haloperidol.

Ritanserin as add-on medication to neuroleptic therapy for patients with chronic or subchronic schizophrenia.

The effect of ritanserin, a potent 5HT 2A/2C receptor antagonist, used as an add-on medication to neuroleptic treatment in patients with schizophrenia, was compared with that of placebo, in an international, double-blind, parallel-group study. Previously established neuroleptic therapy was maintained, and ritanserin 10 mg or placebo was given once daily for 8 weeks. Psychopathology was assessed with the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression (CGI) cale. Safety assessments included the Extrapyramidal Symptom Rating Scale (ESRS), and the requirement for antiparkinsonian medication was monitored. About 70 per cent of patients completed the treatment. There was no difference between the two groups in the numbers of patients with clinical improvement at endpoint on the PANSS negative subscale and total PANSS. The CGIs of overall severity of schizophrenia were better under placebo. The overall prevalence of side effects and the requirements for antiparkinsonism medication were comparable in the two groups. Copyright 2000 John Wiley & Sons, Ltd.