A STUDY TO EVALUATE THE SAFETY OF ARIPIPRAZOLE IN TREATMENT OF SCHIZOPHRENIA

Abstract

Objectives: Aripiprazole is recommended in a dose of 10 and 15 mg/day, with a dose ranging between 10 and 30 mg/day in the treatment of schizophrenia. The primary objective of the study is to evaluate the safety profile of Aripiprazole in low dose of 15 mg versus high dose of 30 mg in the treatment of Schizophrenia.

Methods: A total of 60 patients (not on treatment) between age 18-60 years of either gender who meet the diagnostic criteria as per DSM-IV classification for schizophrenia and schizoaffective disorder. All patients were randomly divided into two groups on single-blind study criteria. Group-I: Aripiprazole 15 mg once a day, morning dose for 6 weeks. Group-II: Aripiprazole 30 mg once a day, morning dose for 6 weeks. The ESRS includes 12 questionnaire items; each item is rated on a 7-point scale. Efficacy assessment included at baseline and at 6 weeks end study scoring on PANSS, EPRS, and CGI.

Results: The total number of patients showed the ESRS (total symptoms) in group-I was 09 patients (35%) out of 26 and in group II, 13 patients (59%) out of total 22 showed the ESRS (total symptoms). In both the groups aripiprazole showed the comparable efficacy by improving overall symptoms in the number of patients. In group I, 20 patients have shown the improvement in overall scores of all scales. In group II, 16 patients have shown the improvement in overall scores in different scales.

Conclusions: Aripiprazole is effective in schizophrenia and schizoaffective disorders, doses of 15 mg are equally effective as doses of 30 mg, side effects like EPS are more with higher doses of Aripiprazole.