Evaluation of efficacy, safety, and cognitive profile of amisulpride per se and its comparison with olanzapine in newly diagnosed schizophrenic patients in an 8-week, double-blind, single-centre, prospective clinical trial.

Abstract

Background. Impaired cognitive functions in schizophrenia are the major deciding factors in response to treatment. Conventional antipsychotics have minimal impact on cognitive dysfunctions and are associated with adverse effects. Atypical antipsychotics have shown promise in treatment of cognitive and negative symptoms of schizophrenia. Efforts are underway to find out the best drug amongst atypical antipsychotics. Objective. To compare efficacy, safety, and cognitive profile of amisulpride and olanzapine in the treatment of acute psychotic exacerbations of schizophrenia. Method. A prospective, randomized, double-blind, single-center, 8-week clinical trial we used. Subjects and Treatments. Seventy four patients were treated for two months with either amisulpride (400-800 mg/d) or olanzapine (10-20 mg/d). Statistics. Mann Whitney U test we used for independent samples with P < 0.05 taken as significant. Results. Brief psychiatric rating scale (BPRS) was used as a primary measure of efficacy. Other measures of efficacy and safety were also evaluated. Both amisulpride and olanzapine groups showed equivalent improvement in psychotic symptoms on BPRS scale. Less than five percent of patients suffered adverse effects only to withdraw from the study. Olanzapine group showed statistically significant (P < 0.05) weight gain compared with amisulpride group. Amisulpride group showed significant improvement (P < 0.05) in various cognitive parameters as compared to olanzapine group.