GEODON Capsules dosing reference - PfizerPro

Arato 2002GEODON vs placebo (1-year schizophrenia study)Results from a prospective, 1-year, double-blind, placebo-controlled, multicenter study of 294inpatients with chronic stable schizophrenia (DSM-III-R) hospitalized for at least 2 months. Priorto enrollment, patients were withdrawn from antipsychotic and anticholinergic medication overa 3-day, single-blind, placebo run-in period. Patients were then randomized to receive eitherGEODON 40 mg/day, 80 mg/day, or 160 mg/day, or placebo for 1 year. Primary efficacy endpoint was time to and rate of impending relapse, as defined by a Clinical Global Impression ofImprovement (CGI-I) score of ≥6 or a score of ≥6 on Positive and Negative Syndrome Scale (PANSS)items P7 (hostility) or G8 (uncooperativeness) persisting for 2 successive days. Patients witha CGI-I score of 5 (minimally worse) were continually monitored until the score either improved(patients remained in study) or deteriorated to ≥6 (much worse or very much worse; patients werewithdrawn from the study). Secondary end points included the Global Assessment of Functioning(GAF) scale administered at 28 and 52 weeks. Patients were weighed at baseline and at Weeks 28and 52. Patients were immediately withdrawn and treated openly if they reached the end point ofimpending relapse.References: 1. Keck PE Jr, Potkin SG, Dunn J, Mandel FS, Ziprasidone in bipolar mania: efficacy across patientsubgroups. Presented at: American Psychiatric Association 56th Institute on Psychiatric Services; October 6-10, 2004;Atlanta, GA. 2. Daniel DG, Zimbroff DL, Potkin SG, Reeves KR, Harrigan EP, Lakshminarayanan M, and the ZiprasidoneStudy Group. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffectivedisorder: a 6-week placebo-controlled trial. Neuropsychopharmacology. 1999;20:491-505. 3. Bowden CL, Vieta E, Ice KS,Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month,randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010;71:130-137. 4. Arato M, O’Connor R, MeltzerHY, on behalf of the ZEUS Study Group. A 1-year, double-blind, placebo-controlled trial of ziprasidone 40, 80, and 160mg/day in chronic schizophrenia: the Ziprasidone Extended Use in Schizophrenia (ZEUS) study. Int Clin Psychopharmacol.2002;17:207-215. 5. IMS Health, June 2010. 6. SDI Health, June 2010. 7. Conley RR, Kelly DL. Drug-drug interactionsassociated with second-generation antipsychotics: considerations for clinicians and patients. Psychopharmacol Bull.2007;40:77-97. 8. Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, andadverse effects. Am Fam Physician. 2007;76:391-396. 9. Wilkinson GR. Drug metabolism and variability among patientsin drug response. N Engl J Med. 2005;352:2211-2221. 10. Spina E, Santoro V, D’Arrigo C. Clinically relevantpharmacokinetic drug interactions with second-generation antidepressants: an update. Clin Ther. 2008;30:1206-1227.11. Robertson P Jr, Hellriegel ET, Arora S, Nelson M. Effect of modafinil on the pharmacokinetics of ethinyl estradiol andtriazolam in healthy volunteers. Clin Pharmacol Ther. 2002;71:46-56.Please see full prescribing information inside pocket.