Clinical Efficacy and Safety Profile of Lurasidone Comparing with Risperidone: Randomized, Open Label, Clinical Study
Journal of Pharmaceutical Research International,
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.
- positive and negative syndrome scale
- suspected adverse drug reactions.
How to Cite
Kane JM. Pharmacologic treatment of schizophrenia. Biol Psychiatry 1999;46:1396-408.
Lieberman JA. Understanding the mechanisms of action of atypical antipsychotic drugs: A review of compounds in use and development. Br J Psychiatry Suppl. 1993;22:7–18.
Casey DE. Extrapyramidal syndromes and new antipsychotic drugs: Findings in patients and non-human primate models. Br J Psychiatry Suppl. 1996;29:32–39.
Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second generation versus first-generation antipsychotic drugs for schizophrenia: A metaanalysis. Lancet. 2009;373:31–41.
Haddad P. Weight change with atypical antipsychotics in the treatment of schizophrenia. J Psychopharmacol. 2005;19:16–27.
H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, Steinberg S, Ernsberger P, Jayathilake K, Meltzer HY, Roth BLNeuropsychopharmacology. 2003;28(3):519-26.
Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. N Engl J Med. 2005;353(12).
Ishibashi T, Horisawa T, Tokuda K, Ishiyama T, Ogasa M, Tagashira R, Matsumoto K, Nishikawa H, Ueda Y, Nakamura M: Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5- HT7) and 5-HT1A receptor activity. J Pharmacol Exp Ther . 2010;334:171–181,.
Tamrakar SM, Nepal MK, Koirala NR, Sharma VD. An open, randomized, comparative study of efficacy and safety of risperidone and haloperidol in schizophrenia; 2006.
Castle D, Wessely S, Der G, Murray RM. The incidence of operationally defined schizophrenia in Camberwell, 1965–84. The British Journal of Psychiatry. 1991;159:790–4.
Häfner H, Löffler W, Maurer K, Hambrecht M, An der Heiden W. Depression, negative symptoms,social stagnation and social decline in the early course of schizophrenia; Acta Psychiatrica Scandinavica. 1999;100:105-18.
Fu L, Ji L, Shen Y, et al. Epidemiological survey on mental disability and intellectual impairment in 7 areas of China. Chinese Journal of Psychiatry. 1998;31:81–83.
Li XJ, Wu JH, Liu JB, Li KP, Wang F, Sun XH, et al. The influence of marital status on the social dysfunction of schizophrenia patients in community. Int J Nurs Sci. 2015;2:149-52.
Carsten Bøcker Pedersen. Preben Bo Mortensen Family history, place and season of birth as risk factors for schizophrenia in Denmark: A replication and reanalysis. 2018;179 (1):46-52.
Miles CP. Conditions predisposing to suicide: A review. J Nerv Ment Dis. 1977;164:231–246.
Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353(12):1209–1223.
Samalin, Ludovic, Marion Garnier, Pierre-Michel Llorca. “Clinical potential of lurasidone in the management of schizophrenia.” Therapeutics and Clinical Risk Management. 2011;7:239–250.
Kirkpatrick B, Fenton WS, Carpenter WT Jr, Marder SR. The NIMH- MATRICS consensus statement on negative symptoms. Schizophr. Bull. 2006;32:214–219.
Steven GP, Robert EL, Rosarelis T, Curt DW. Efficacy of iloperidone in the treatment of schizophrenia initial phase 3 studies. Journal of Clinical Psychopharmacology. 2008;28(2);4-11.
Gupta A, Dadheech G, Yadav D, Sharma P, Gautam S. Metabolic issues in schizophrenic patients receiving antipsychotic treatment. Indian Journal of Clinical Biochemistry. 2014;29(2):196-201.
Wetterling T. Bodyweight gains with a typical antipsychotics a comparative review. Drug Safety. 2001;24(1):59-74.
Peter JW, Andrew JC, Mihael HP, Curt DW. Safety profile of iloperidone a pooled analysis of 6-week acute-phase pivotal trials. J Clin Psychopharmacol. 2008;28:12-9.
Abstract View: 0 times
PDF Download: 0 times