RESUMO
Background: Schizophrenia is a functional psychosis with severe personality changes and thought disorders without cerebral damage. No reports are available in literature regarding efficacy and tolerability of atypical antipsychotic drug zotepine over olanzapine a preferred drug worldwide for the treatment of schizophrenia. Therefore, present study is undertaken to evaluate efficacy, tolerability and cost effectiveness of zotepine over olanzapine in patients suffering from schizophrenia. Methods: A prospective, randomized, single blind, parallel, 6 weeks clinical study was conducted on a total of 112 patients, of schizophrenia attending psychiatry outpatient department at G. R. Medical College, Gwalior, India randomized into two groups (56 in each). Patients received either olanzapine (10-20mg) or zotepine (75-150mg) per day for a period of 6 week. Efficacy was measured by Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression (CGI) scale whereas tolerability was measured by dropout rate and frequency of adverse effects. Cost effectiveness was calculated in terms of cost incurred for improvement at the end of treatment period. Results: Both the drugs showed significant (P<0.05) improvement in PANSS total score as compared to their respective baseline scores however, there was no significant difference between the two groups (P>.0.05). Olanzapine showed significantly better (P<0.05) positive subscale and CGI scale score improvement as well as response rate when compared to zotepine. Incidences of adverse effects like weight gain, somnolence and hyperglycemia were 42, 32 and12 % respectively with olanzapine and 39, 30 and 9% respectively with zotepine with no significant difference (P>0.05) between the two groups. Incidence of akathisia and drop out (16% and 23%) with zotepine were significant (P<0.05) as compared to olanzapine (2% and 11%) respectively. Conclusions: Though the efficacy of both the drugs is comparable, olanzapine appears to have better tolerability and cost effectiveness than zotepine in patients of schizophrenia.