THE LESSA (Lebanese Short-term Study with Amisulpride) STUDY a Phase IV clinical trial in acutely ill schizophrenic patients.

BACKGROUND: Conventional antipsychotics have relatively moderate efficacy against schizophrenic negative symptoms and are associated with significant adverse events.

OBJECTIVES: To assess the clinical safety and efficacy of Solian (amisulpride), an atypical antipsychotic agent of the benzamide family.

PATIENTS AND METHODS: This is an 8-week cohort study including adults with schizophrenia. Daily dose was between 400 and 800 mg. Safety was measured as the cumulative risk of adverse events and efficacy as the physician's global assessment of global improvement on an ordinal scale from 0 to 6. An efficacy index, a composite measure of both safety and efficacy, was also measured on an ordinal scale from 16 the worst to 1 the best.

RESULTS: Fifty-seven patients were included. Eight patients (14%) experienced at least one adverse event during the trial, mainly extra-pyramidal symptoms (EPS). None required treatment discontinuation and none was qualified as serious. Four required corrective treatment and six resolved during the 8-week follow-up. On the Global Improvement scale 31.6% of patients were "very much" or "much improved" on D14 and 81.8% on D56. 25.5% of subjects achieved complete remission over the study period. Improvement reflected also on the efficacy index, decreasing from 8.2 (SD : 3.1) on D14 to 3.4 (SD: 2.9) on D56.

CONCLUSION: Amisulpride, in addition to its well-established efficacy in schizophrenic patients, offers a particularly good safety profile.