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Titolo:
Phase-IV multicentre clinical study of risperidone in the treatment of outpatients with schizophrenia
Autore:
Chouinard, G; Kopala, L; Labelle, A; Beauclair, L; Johnson, SV; Singh, KI;
Indirizzi:
Louis H Lafontaine Hosp, Module Psychopharmacol Clin, Montreal, PQ H1N 3M5, Louis H Lafontaine Hosp Montreal PQ Canada H1N 3M5 Montreal, PQ H1N 3M5, Allan Mem Inst, Montreal, PQ, Canada Allan Mem Inst Montreal PQ CanadaAllan Mem Inst, Montreal, PQ, Canada Dalhousie Univ, Dept Psychiat, Halifax, NS B3H 3J5, Canada Dalhousie UnivHalifax NS Canada B3H 3J5 iat, Halifax, NS B3H 3J5, Canada Royal Ottawa Hosp, Schizophrenia Serv, Ottawa, ON, Canada Royal Ottawa Hosp Ottawa ON Canada chizophrenia Serv, Ottawa, ON, Canada McGill Univ, Dept Psychiat, Montreal, PQ H3A 2T5, Canada McGill Univ Montreal PQ Canada H3A 2T5 hiat, Montreal, PQ H3A 2T5, Canada Mem Univ Newfoundland, Waterford Hosp, St Johns, NF, Canada Mem Univ Newfoundland St Johns NF Canada ford Hosp, St Johns, NF, Canada Vancouver Hosp & Hlth Sci Ctr, Vancouver, BC V5Z 1M9, Canada Vancouver Hosp & Hlth Sci Ctr Vancouver BC Canada V5Z 1M9 V5Z 1M9, Canada
Titolo Testata:
CANADIAN JOURNAL OF PSYCHIATRY-REVUE CANADIENNE DE PSYCHIATRIE
fascicolo: 10, volume: 43, anno: 1998,
pagine: 1018 - 1025
SICI:
0706-7437(199812)43:10<1018:PMCSOR>2.0.ZU;2-0
Fonte:
ISI
Lingua:
ENG
Soggetto:
DOUBLE-BLIND; HALOPERIDOL; WITHDRAWAL; SCALE; DRUGS;
Keywords:
risperidone; schizophrenia; psychosis; antipsychotics; neuroleptics; atypical antipsychotics; serotonin; dopamine; extrapyramidal symptoms;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Social & Behavioral Sciences
Clinical Medicine
Citazioni:
19
Recensione:
Indirizzi per estratti:
Indirizzo: Chouinard, G Louisontreal,taine Hosp, Module Psychopharmacol Clin, 7401 Rue Hochelaga, M Louis H Lafontaine Hosp 7401 Rue Hochelaga Montreal PQ Canada H1N 3M5
Citazione:
G. Chouinard et al., "Phase-IV multicentre clinical study of risperidone in the treatment of outpatients with schizophrenia", CAN J PSY, 43(10), 1998, pp. 1018-1025

Abstract

Objective: Since most clinical trials of atypical antipsychotics have beenconducted in hospitalized patients, a Phase-IV, multicentre, 8-week, open-label, flexible-dose study was performed to assess the efficacy and safety of risperidone in outpatients with schizophrenia. Method: Three hundred and thirty patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R) diagnosis of schizophrenia were enrolled at 61 Canadian sites. Upon trial entry, the patients had their neuroleptic and antiparkinsonian drugs discontinued, and treatment with risperidone was initiated at a dose of 2 mg daily, then increased by 2 mg daily on each of the 2 following days until the initial target dose of 6 mg daily was reached on day 3. No further titration was allowed until day 14, after which the dose could be increased or decreased. Results: During the stabilization phase (days 14-56), the dose was unchanged in 44% of the patients, increased in 24%, decreased in 23%, and titratedboth lap and down in 9% of the patients. In the efficacy-evaluable population (n = 292), treatment with risperidone produced substantial (-26.4) and significant (P = 0.0001) improvement in the total Positive and Negative Syndrome Scale (PANSS) score. At the end of the study (week 8), 85% of patients were classified as clinically improved according to an a priori definition (that is, 20% or more decrease from baseline in total PANSS score). On their last study visit, 75% of patients reported their experience with risperidone as better than their previous neuroleptic therapy. Risperidone was generally well tolerated. The adverse events reported by more than 5% of the patients, were insomnia, nausea, headache, somnolence, dizziness, fatigue, anxiety, vomiting, and ejaculation disorder. Seventy-four percent of the reported treatment-related adverse events were recorded during the first 2 weeks of the trial, possibly because of the discontinuation of prior neuroleptic and antiparkinsonian drugs followed by immediate upward titration of risperidone. However, only 8. 5% of adverse events were reported to have occurred during week 3, and only 0.8% of adverse events were reported for week 8. Risperidone treatment produced significant improvements over baseline inthe incidence and severity of extrapyramidal symptoms (EPS). A slight but statistically significant increase in body weight was observed. Conclusions: The results of this open-label, Phase-IV trial in a large population of outpatients with schizophrenia found that risperidone was superior to the neuroleptics that patients had previously taken in terms of efficacy and severity of EPS. Our results suggest the use of risperidone at lower doses in outpatients with schizophrenia.

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Documento generato il 19/01/20 alle ore 20:27:33