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In the present 6-week double-blind, randomised, multicentre study, the atypical neuroleptic remoxipride was compared to haloperidol in acute schizophrenic patients (DSM-III). Seventy-one patients entered the study, 36 in the remoxipride group and 35 in the haloperidol group. There were ten early withdrawals, four in the remoxipride group and six patients in the haloperidol group. The Present State Examination (PSE) profile revealed a similar reduction in the symptom clusters of psychosis in both treatment groups. Forty-seven per cent of the patients in the remoxipride group and 34% of the patients in the haloperidol group showed clinically relevant improvement (reduction of BPRS total score greater than or equal to 50%). All extrapyramidal symptoms except "glabella tap" occurred significantly less frequently in the remoxipride group as compared to the haloperidol group. Substantially lower incidences of EPS were found by active questioning in the remoxipride group compared to the haloperidol group. In addition, considerably lower incidences were observed in the remoxipride group with respect to drowsiness/somnolence, tiredness/fatigue and concentrating difficulty. At the end of treatment 66% of the patients in the haloperidol group and 22% in the remoxipride group were using anticholinergics. No consistent changes were found in the mean plasma HVA level in either treatment group. In responders (reduction of BPRS total score greater than or equal to 50%) lower baseline HVA levels were observed in both treatment groups. This study indicates that the newly developed neuroleptic remoxipride is an effective antipsychotic compound, which is clinically safe and well tolerated. In particular, few EPS were induced by remoxipride, as compared to haloperidol.

In a six-week double-blind randomized trial, preceded by a one-week single-blind placebo treatment, the efficacy and the side-effects of fluoxetine (40-80 mg/d) (n = 30) and maprotiline (50-150 mg/d) (n = 35) were compared in hospitalized patients with DSM-III Major Depression without psychotic features. Efficacy was measured by means of the Hamilton Depression Rating Scale, the Raskin Depression Scale, the Covi Anxiety Scale, and a Clinical Global Impression. Side-effects were evaluated by an Adverse Events Scale. A statistically significant improvement was achieved in both treatment groups but success rates were modest. No differences in efficacy were found between the two groups. In addition, no statistically significant differences were found between the two groups either in frequency or in severity of adverse events. In fact, the only statistically significant difference found was in weight change: weight loss in the fluoxetine group and weight gain in the maprotiline group.

Seventy-one patients were entered into a multicentre, double-blind randomized study to compare the efficacy and safety of remoxipride with those of haloperidol in the acute treatment of schizophrenia or schizophreniform disorder. The patients, who were well-matched regarding demographic characteristics, were aged 18-64 years. Four patients in the remoxipride group and 6 in the haloperidol group discontinued treatment prematurely. The mean daily doses during the last week of treatment were 363 mg remoxipride and 9 mg haloperidol. At this time 22% of patients on remoxipride and 66% of those on haloperidol were taking anticholinergics (p less than 0.001). The clinical efficacy was similar in both groups as judged by Present State Examination (PSE) profile and Brief Psychiatric Rating Scale (BPRS) ratings. Several adverse symptoms occurred significantly more frequently during treatment with haloperidol than with remoxipride, particularly where extrapyramidal symptoms were concerned. No clinically relevant changes occurred in the laboratory tests in either group.