Ninety‐two patients with schizophrenia were included in a double‐blind multicentre parallel‐group trial comparing remoxipride and haloperidol. The mean daily dose during the last week of treatment was 316 mg (range, 150–600 mg) in the remoxipride group and 8.7 mg (range, 5–20 mg) in the haloperidol group. The study period was six weeks with at least one day of washout. Both Clinical Global Impression (CGI) rating, and Brief Psychiatric Rating Scale (BPRS) total scores declined at the end of the trial compared with pretreatment values in both groups. No significant differences were found between the remoxipride and haloperidol groups with regard to the treatment outcome. Treatment‐emergent extrapyramidal symptoms were statistically more frequent and more severe during haloperidol than during remoxipride treatment. Haloperidol‐treated patients reported also significantly more concentration difficulties. Severe extrapyramidal side effects in the haloperidol group and clinical ineffectiveness in the remoxipride group were the most frequent reasons for premature discontinuation of treatment.
The purpose of this study was to assess the tolerability and efficacy of 150-600 mg remoxipride (predominantly a DA2 receptor antagonist) in an open long-term (1 year) multicentre trial in chronic schizophrenic patients. The mean duration of illness before entering the study was 21 years and the pre-study neuroleptic dosage in chlorpromazine equivalents was 930 mg/day. The clinical efficacy was measured with the Brief Psychiatric Rating Scale and the Clinical Global Impression scale. The adverse events were recorded by a 26-item Adverse Symptom Checklist and by the Abnormal Involuntary Movements Scale. Forty-five patients were included in the study. The mean daily dose of remoxipride during the last week of treatment was 378 mg. Eighty percent (36 patients) withdrew prematurely (< 1 year). The main reasons for withdrawal were: ineffectiveness (n = 15), treatment refusal (n = 12) and adverse events (n = 8). The most frequently reported adverse events were insomnia (n = 20) and tiredness (n = 7), whereas only a few (n = 6) extrapyramidal symptoms were reported. There was no relationship between remoxipride plasma concentration and clinical efficacy nor was any relationship found between the ratio of pretrial chlorpromazine equivalent to last remoxipride dose and the therapeutic effect. Remoxipride alone seemed to have an insufficient neuroleptic efficacy in these chronic and treatment-resistant schizophrenic patients but was well tolerated.
SUMMARYA four-week double-blind study of zuclopenthixol and thioridazine in 64 elderly patients presenting with hostility or restlessness has been carried out in five Finnish mental hospitals. The ages of the patients in the two groups ranged from 64 to 97 years. The initial daily dose was 2-6 mg zuclopenthixol or 20-60 mg thioridazine. In week 4 the mean daily dose was 6.8 mg zuclopenthixol and 62 mg thioridazine. After one week of treatment the severity of illness was reduced significantly in the zuclopenthixol group and in both groups after two and four weeks. The key symptom hostility showed significant improvement in both treatment groups after only one week of treatment. The other key symptom restlessness was also significantly improved in both groups. The only significant difference between the groups was a better effect on sleep disturbance with zuclopenthixol. Few side-effects were recorded in either group, and no serious effects on cardiovascular function were found. The study indicates that both zuclopenthixol and thioridazine are effective drugs in the treatment of elderly patients with symptoms such as hostility, aggressiveness and restlessness.
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