clopenthixol-acetate-ester and Dyskinesia--Drug-Induced

We carried out a 9-day double-blind clinical trial comparing intramuscular zuclopenthixol acetate with liquid oral haloperidol in the treatment of 40 newly admitted schizophrenic patients with acute exacerbation. A parallel-group design was used with stratification by sex. Zuclopenthixol acetate (50 to 150 mg) was given intramuscularly every 3 days, whereas liquid haloperidol (10 to 30 mg daily) was given orally three times a day, with supplementary doses of each medication given under double-blind conditions when needed for agitation. No other sedative drugs, including benzodiazepines, were administered. The mean daily dose was 18.9 mg for haloperidol as compared with a mean dose per 3 days of 117.6 mg for zuclopenthixol. The two treatments were found to be equally efficacious on the Brief Psychiatric Rating Scale and Clinical Global Impression Scale. Both drugs induced similar extrapyramidal side effects. However, more tremors were associated with zuclopenthixol as was a tendency for tardive dyskinesia to be unmasked at the end of the injection interval. Sedation was higher with zuclopenthixol acetate than with haloperidol. Serum creatinine phosphokinase levels were not significantly increased after zuclopenthixol injections. The results of this trial suggest that zuclopenthixol acetate given intramuscularly every second to third day offers an alternative to conventional liquid oral haloperidol in the management of acute schizophrenia.

Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Antipsychotic Agents; Arousal; Clopenthixol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Dyskinesia, Drug-Induced; Female; Haloperidol; Humans; Injections, Intramuscular; Male; Middle Aged; Neurologic Examination; Prolactin; Psychiatric Status Rating Scales; Schizophrenia; Schizophrenic Psychology

Twenty-five acutely disturbed psychotic patients were treated in an open study with a single injection of zuclopenthixol acetate 5% in 'Viscoleo, a thin vegetable oil. Patients were assessed post-injection for 3 days using the BPRS, CGI, and a specially designed behaviour/activity scale. Doses of 50 to 150 mg proved effective in 24 (96%) of 25 patients, with pronounced and rapid reduction in psychotic symptoms over the study period. The mean total BPRS score after 72 hours was reduced by over 57%. Tranquillization and sedation appeared within 15 to 90 minutes of injection. Unwanted symptoms were generally mild and of low incidence. The results showed that a single injection of zuclopenthixol acetate 5% in 'Viscoleo' provided rapid tranquillization and sedation coupled with an antipsychotic effect over 3 days. This profile offers a distinct advantage over neuroleptic preparations conventionally used for the initial treatment of acutely disturbed psychotic patients.

Topics: Adult; Antipsychotic Agents; Clopenthixol; Dyskinesia, Drug-Induced; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Psychiatric Status Rating Scales; Psychotic Disorders; Thioxanthenes