THE LESSA (Lebanese Short-term Study with Amisulpride) STUDY a Phase IV clinical trial in acutely ill schizophrenic patients
Author: Baddoura R, Ourgandjian H
Source:
The Lebanese Medical Journal, 52(2), 78-85.
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 schizophreni
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