Clinical Efficacy and Safety Profile of Lurasidone Comparing with Risperidone: Randomized, Open Label, Clinical Study

Abstract

There are diverse studies which afford evidences that risperidone is as effective as second generation antipsychotics in treating positive symptoms and more effective in treatment of negative symptoms. This study is intended to find the clinical efficacy and safety profile of lurasidone comparing with risperidone, a drug in common use nowadays. Patients aged between 18 to 60yrs, Patients with new onset of symptoms who fulfil the ICD-10 criteria for a primary diagnosis of schizophrenia and Patients having a total PANSS score of ≥80 including a score ≥4 (moderate) on two or more of positive subscale at baseline. Patients with acute exacerbation of schizophrenia who remained drug free for at least last 6 months also included. Demographic data of the patients were collected. Baseline investigations like BP, complete blood count, lipid profile, blood sugar, renal function test and liver function test were done. Severity of schizophrenia at baseline was assessed using positive and negative symptoms scale (PANSS). Patients were randomized by using computer generated random table in 1:1 ratio as group A and group B, with 25 patients in each group. The efficacy of group A and group B was analysed by applying rating scale Positive and negative syndrome scale (PANSS) at the end of 4 and 6 weeks. Adverse drug reactions were recorded and monitored by interviewing with patients, by physical examination and also by necessary lab investigations at the end of 6 weeks. Patients were insisted to maintain a diary to note any new occurrence of adverse drug reactions in between the follow up period. Suspected adverse drug reactions were documented in predesigned reporting form. In PANSS positive scale both groups had significant decrease in PANSS score both at week 4 and week 6 (p<0.05). Lurasidone is as equally efficacious as risperidone in reducing PANSS score, but produces less metabolic syndrome and other adverse effects than risperidone.