[Efficacy of zuclopenthixol acetate on psychotic anxiety evaluated in an open study]

The first scale evaluating psychotic anxiety specifically is the "Psychotic Anxiety Scale": PAS was proposed and validated by O. Blin et al. in 1988. Zuclopenthixol acetate formulation is a both rapid and middle prolonged (2-3 days) acting neuroleptic used to start the treatment in an acute episode of the psychotic illness. It has been established as an effective drug for a broad spectrum of symptoms in schizophrenia and other psychosis, but its "angolytic" effect had never been quantified. It was interesting to study the efficacy of zuclopenthixol acetate on psychotic anxiety with PAS during the first 9 days of hospitalisation of psychotic patients. During the study, the clinical evaluation was made with the Psychotic Anxiety Scale (PAS) for the main criteria; Clinical Global Impression (CGI) and the Nordic side effect scale (UKU) for the secondary criteria. Assessments were performed at days, 0, 1, 3, 4, 6, 7 and 9. Zuclopenthixol acetate was administered at Day 0, Day 3, and Day 6. Protocol allowed an additional injection at D1 in case of insufficient efficacy. Forty six patients were included into this open non comparative multicenter study: 23 patients were male and 23 female. Their mean age (X +/- S) was 32 +/- 10 years, and according to DSM III-R, 28 of them got schizophrenia diagnosis, 13 suffered from brief psychotic disorder and 3 from schizophreniform disorder (diagnosis was missing for two subjects). The mean dosage of zuclopenthixol acetate by injection, foreseen in the protocol, was between 126 to 138 mg. Four patients were treated with high dose: more than 800 mg during the 9 days of the study and 6 patients had 5 injections or more. Between D0 and D9, the total PAS score decreased from 63 (from moderated to severe anxiety) to 25 (absence of anxiety) and the reduction of score was statistically significant from 24 hours after the first injection (p < 0.01). Various items analysis of PAS has showed a statistically significant reduction from 24 hours for all items (p < 0.01) except for physical depersonalisation, inhibition of thought and motor inhibition. Assessment index of therapeutic effect (CGI 2) decreased in a statistically significant way from 72 hours (p = 0.01). Globally, we found a good correlation between Clinical Global Impression and PAS, it was maximal and significant at day 7 (r = 0.87). According to the UKU scale and the investigators, the treatment was well tolerated. The results suggest that zuclopenthixol acetate is an effective and reliable way to initiate neuroleptic treatment with an statistically significant activity in psychotic anxiety from 24 hours.