498
Views
11
CrossRef citations to date
0
Altmetric
Drug Evaluation

Evaluation of the pharmacokinetics, safety and clinical efficacy of ziprasidone for the treatment of schizophrenia and bipolar disorder

, &

Bibliography

  • van Os J, Kapur S. Schizophrenia. Lancet 2009;374:635-45
  • Andreasen NC. Symptoms, signs, and diagnosis of schizophrenia. Lancet 1995;346:477-81
  • Picchioni MM, Murray RM. Schizophrenia. BMJ 2007;335:91-5
  • Saha S, Chant D, McGrath J. A systematic review of mortality in schizophrenia: is the differential mortality gap worsening over time? Arch Gen Psychiatry 2007;64:1123-31
  • Capuano B, Crosby IT, Lloyd EJ. Schizophrenia: genesis, receptorology and current therapeutics. Curr Med Chem 2002;9:521-48
  • Stahl SM. Psychopharmacology of antipsychotics. Martin Dunitz; London: 1999
  • Dixon LB, Lehman AF, Levine J. Conventional antipsychotic medications for schizophrenia. Schizophr Bull 1995;21:567-77
  • Kane JM. Drug therapy: schizophrenia. N Engl J Med 1996;334:34-41
  • Love RC. Novel versus conventional antipsychotic drugs. Pharmacotherapy 1996;16:6-10
  • Emsley RA. Partial response to antipsychotic treatment: the patient with enduring symptoms. J Clin Psychiatry 1999;60(Suppl 23):10-13
  • Chue P, Malla A, Bouchard R-H, et al. The long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release in patients with schizophrenia. Curr Med Res Opin 2013;29:227-39
  • Guo X, Fang M, Zhai J, et al. Effectiveness of maintenance treatments with atypical and typical antipsychotics in stable schizophrenia with early stage: 1-year naturalistic study. Psychopharmacology (Berl) 2011;216:475-84
  • Jones PB, Barnes TR, Davies L, et al. Randomized controlled trial of the effect on quality of life of second- vs. first-generation antipsychotic drugs in schizophrenia: cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLAS 1). Arch Gen Psychiatry 2006;63:1079-87
  • Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of anti- psychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353:1209-23
  • Buckley PF. Broad therapeutic profile of atypical antipsychotics. Biol Psychiatry 2001;50:912-14
  • Miller R. Mechanisms of action of antipsychotic drugs of different classes, refractoriness to therapeutic effects of classical neuroleptics, and individual variation in sensitivity to their actions: part I. Curr Neuropharmacol 2009;7:302-14
  • Farah A. Atypicality of atypical antipsychotics. Prim Care Companion J Clin Psychiatry 2005;7:268-74
  • Collaborative Working Group on Clinical Trial Evaluations. Adverse effects of the atypical antipsychotics. J Clin Psychiatry 1998;59(Suppl 12):17-22
  • Kearns AE, Goff DC, Hayden DL, Daniels GH. Risperidone-associated hyperprolactinemia. Endocr Pract 2000;6:425-9
  • Tohen M, Sanger TM, McElroy SL, et al. Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group. Am J Psychiatry 1999;156:702-9
  • Sachs GS, Grossman F, Ghaemi SN, et al. Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-controlled comparison of efficacy and safety. Am J Psychiatry 2002;159:1146-54
  • Keck PEJr, Versiani M, Potkin S, et al. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry 2003;160:741-8
  • Sachs G, Chengappa KN, Suppes T, et al. Quetiapine with lithium or divalproex for the treatment of bipolar mania: a randomized, double-blind, placebo-controlled study. Bipolar Disord 2004;6:213-23
  • Perlis RH, Welge JA, Vornik LA, et al. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry 2006;67:509-16
  • Mattei C, Rapagnani MP, Stahl SM. Ziprasidone hydrocloride: what role in the management of schizophrenia? J Cent Nerv Syst Dis 2011;3:1-16
  • Bilder RM, Goldman RS, Volavka J, et al. Neurocognitive effects of clozapine, olanzapine, risperidone, and haloperidol in patients with chronic schizophrenia and schizoaffective disorder. Am J Psychiatry 2002;159:1018-28
  • Schatzberg AF, Nemeroff CB. editors. Essentials of clinical psychopharmacology. American Psychiatric Publishing; Arlington: 2013
  • Drugs.com, Pharmaceutical sales 2003-2012. Available from: http://www.drugs.com/top200_2003.html [Last accessed 3 November 2014]
  • California Association of Toxicologists, Ziprasidone monograph. Available from: http://www.cal-tox.org/Downloads/monographs/ziprasidone.pdf [Last accessed 20 February 2014]
  • US Department of Health & Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, NDA 20-825 approval letter. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20825ltr.pdf [Last accessed 20 February 2014]
  • US Department of Health & Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, NDA 20-825/S-009 approval letter. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009rev2.pdf
  • US Department of Health & Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, NDA 20-825/S-034 approval letter. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020825Orig1s034.pdf
  • Ferrando SJ, Owen JA, Levenson JL. Psychopharmacology. In: Hales RE, Yudofsky SC, Gabbard GO, editors. The American psychiatric publishing textbook of psychiatry. 5th edition. American Psychiatric Publishing; Arlington: 2008
  • Strom BL, Eng SM, Faich G, et al. Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psychiatry 2011;168:193-201
  • US Department of Health & Human Services, Food and Drug Administration, Drugs@FDA, Ziprasidone hydrochloride approval history. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/indexcfm?fuseaction=SearchOverview&DrugName=ZIPRASIDONE%20HYDROCHLORIDE [Last accessed 20 February 2014]
  • RaQualia Out-Licensed programs. Available from: http://www.raqualia.com/product/contract.html [Last accessed 20 February 2014]
  • Human Metabolome Database Version 35, metabocard for Ziprasidone (HMDB14391). Available from: http://www.hmdb.ca/metabolites/HMDB14391#physical-properties [Last accessed 20 February 2014]
  • US Department of Health & Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, NDA 20-919 approval package – Clinical Pharmacology and Biopharmaceutics Review. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-919_geodon_biopharmr.pdf [Last accessed 20 February 2014]
  • Walash MI, Belal F, El-Enany N, et al. Stability-indicating spectrofluorimetric method for the assay of ziprasidone in capsules. J Fluoresc 2011;21:1659-67
  • Pfizer, Inc. Geodon prescribing information. 2014. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=584 [Last accessed 3 November 2014]
  • Schmidt AW, Lebel LA, Howard HRJr, Zorn SH. Ziprasidone: a novel antipsychotic agent with a unique human receptor binding profile. Eur J Pharmacol 2001;425:197-201
  • Richelson E, Souder T. Binding of antipsychotic drugs to human brain receptors focus on newer generation compounds. Life Sci 2000;68:29-39
  • Mamo D, Kapur S, Shammi CM, et al. A PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone. Am J Psychiatry 2004;161:818-25
  • Vernaleken I, Fellows C, Janouschek H, et al. Striatal and extrastriatal D2/D3-receptor-binding properties of ziprasidone: a positron emission tomography study with [18F]fallypride and [11C]raclopride (D2/D3-receptor occupancy of ziprasidone). J Clin Psychopharmacol 2008;28:608-17
  • Stahl SM, Shayegan DK. The psychopharmacology of ziprasidone: receptor-binding properties and real-world psychiatric practice. J Clin Psychiatry 2003;64:6-12
  • Rollema H, Lu Y, Schmidt AW, et al. 5-HT1A receptor activation contributes to ziprasidone-induced dopamine release in the rat prefrontal cortex. Biol Psychiatry 2000;48:229-37
  • Raggi MA, Mandrioli R, Sabbioni C, et al. Atypical antipsychotics: pharmacokinetics, therapeutic drug monitoring and pharmacological interactions. Curr Med Chem 2004;11:279-96
  • Raggi MA, Mandrioli R, Pucci V, et al. Advances in therapeutic drug monitoring of atypical antipsychotic drugs. Med Chem Rev Online 2004;1:299-316
  • Expert Consensus Panel for Optimizing Pharmacologic Treatment of Psychotic Disorders. Optimizing pharmacologic treatment of psychotic disorders. J Clin Psychiatry 2003;64(Suppl 12):2-97
  • Gardner DM, Murphy AL, Kutcher S, et al. Evidence review and clinical guidance for the use of ziprasidone in Canada. Ann Gen Psychiatry 2013;12:1-19
  • Citrome L, Reist C, Palmer L, et al. Impact of real-world ziprasidone dosing on treatment discontinuation rates in patients with schizophrenia or bipolar disorder. Schizophr Res 2009;115:115-20
  • Citrome L, Yang R, Glue P, Karayal ON. Effect of ziprasidone dose on all-cause discontinuation rates in acute schizophrenia and schizoaffective disorder: a post-hoc analysis of 4 fixed-dose randomized clinical trials. Schizophr Res 2009;111:39-45
  • Miceli JJ, Wilner KD, Hansen RA, et al. Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers. Br J Clin Pharmacol 2000;49:5S-13S
  • Miceli JJ, Glue P, Alderman J, et al. The effect of food on the absorption of oral ziprasidone. Psychopharmacol Bull 2007;40:58-68
  • Hamelin BA, Allard S, Laplante L, et al. The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone. Pharmacotherapy 1998;18:9-15
  • Gandelman K, Alderman JA, Glue P, et al. The impact of calories and fat content of meals on oral ziprasidoneabsorption: a randomized, open-label, crossover trial. J Clin Psychiatry 2009;70:58-62
  • Preskorn S, Ereshefsky L, Chiu Y-Y, et al. Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies. Hum Psychopharmacol 2013;28:495-505
  • Citrome L. Vilazodone for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant – what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int J Clin Pract 2012;66:356-68
  • US Food and Drug Administration, Center for Drug Evaluation and Research, Application number: 022567Orig1s000 - Clinical Pharmacology and Biopharmaceutics Review(s). 2010. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000ClinPharmR.pdf [Last accessed 10 November 2014
  • Miceli JJ, Wilner KD, Swan SK, et al. Pharmacokinetics, safety, and tolerability of intramuscular ziprasidone in healthy volunteers. J Clin Pharmacol 2005;45:620-30
  • Preskorn SH. Pharmacokinetics and therapeutics of acute intramuscular ziprasidone. Clin Pharmacokinet 2005;44:1117-33
  • Aweeka F, Jayesekara D, Horton M, et al. The pharmacokinetics of ziprasidone in subjects with normal and impaired renal function. Br J Clin Pharmacol 2000;49:27S-33S
  • Everson G, Lasseter KC, Anderson KE, et al. The pharmacokinetics of ziprasidone in subjects with normal and impaired hepatic function. Br J Clin Pharmacol 2000;49:21S-6S
  • Wilner KD, Tensfeldt TG, Baris B, et al. Single- and multiple-dose pharmacokinetics of ziprasidone in healthy young and elderly volunteers. Br J Clin Pharmacol 2000;49:15S-20S
  • Sallee FR, Miceli JJ, Tensfeldt T, et al. Single-dose pharmacokinetics and safety of ziprasidone in children and adolescents. J Am Acad Child Adolesc Psychiatry 2006;45:720-8
  • Obach RS, Prakash C, Kamel AM. Reduction and methylation of ziprasidone by glutathione, aldehyde oxidase, and thiol S-methyltransferase in humans: an in vitro study. Xenobiotica 2012;42:1049-57
  • Prakash C, Kamel A, Cui D, et al. Identification of the major human liver cytochrome P450 isoform(s) responsible for the formation of the primary metabolites of ziprasidone and prediction of possible drug interactions. Br J Clin Pharmacol 2000;49:35S-42S
  • Beedham C, Miceli JJ, Obach RS. Ziprasidone metabolism, aldehyde oxidase, and clinical implications. J Clin Psychopharmacol 2003;23:229-32
  • Caccia S. N-dealkylation of arylpiperazine derivatives: disposition and metabolism of the 1-arylpiperazines formed. Curr Drug Metab 2007;8:612-22
  • Miceli JJ, Smith M, Robarge L, et al. The effects of ketoconazole on ziprasidone pharmacokinetics - a placebo-controlled crossover study in healthy volunteers. Br J Clin Pharmacol 2000;49:71S-6S
  • Miceli JJ, Anziano RJ, Robarge L, et al. The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers. Br J Clin Pharmacol 2000;49:65S-70S
  • Obach RS, Huynh P, Allen MC, Beedham C. Human liver aldehyde oxidase: inhibition by 239 drugs. J Clin Pharmacol 2004;44:7-19
  • Obach RS, Walsky RL. Drugs that inhibit oxidation reactions catalyzed by aldehyde oxidase do not inhibit the reductive metabolism of ziprasidone to its major metabolite, S-methyldihydroziprasidone. An in vitro study. J Clin Psychopharmacol 2005;25:605-8
  • Prakash C, Kamel A, Gummerus J, et al. Metabolism and excretion of a new antipsychotic drug, ziprasidone, in humans. Drug Metab Dispos 1997;25:863-72
  • Holthoewer D, Kirschbaum KM, Frisch J, et al. Pharmacodynamic effects of aripiprazole and ziprasidone with respect to P-glycoprotein substrate properties. Pharmacopsychiatry 2013;46:175-80
  • Hodges LM, Markovac SM, Chinn LW, et al. Very important pharmacogene summary: ABCB1 (MDR1, P-glycoprotein). Pharmacogenet Genomics 2011;21:152-61
  • Summerfield SG, Stevens AJ, Cutler L, et al. Improving the in vitro prediction of in vivo central nervous system penetration: integrating permeability, P-glycoprotein efflux, and free fractions in blood and brain. J Pharmacol Exp Ther 2006;316:1282-90
  • Stip E, Zhornitsky S, Moteshafi H, et al. Ziprasidone for psychotic disorders: a meta-analysis and systematic review of the relationship between pharmacokinetics, pharmacodynamics, and clinical profile. Clin Ther 2011;33:1853-67
  • Apseloff G, Mullet D, Wilner KD, et al. The effects of ziprasidone on steady-state lithium levels and renal clearance of lithium. Br J Clin Pharmacol 2000;4:61S-4S
  • Miodownik C, Hausmann M, Frolova K, Lerner V. Lithium intoxication associated with intramuscular ziprasidone in schizoaffective patients. Clin Neuropharmacol 2005;28:295-7
  • Borovicka MC, Bond LC, Gaughan KM. Ziprasidone- and lithium-induced neuroleptic malignant syndrome. Ann Pharmacother 2006;40:139-42
  • Dubovsky SL, Dubovsky AN. Maintenance treatment of bipolar disorder with ziprasidone in adjunctive use with lithium or valproate. Clin Med Insights Ther 2012;4:1-8
  • Bowden CL, Vieta E, Ice KS, et al. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry 2010;71:130-7
  • Greenberg WM, Citrome L. Ziprasidone for schizophrenia and bipolar disorder: a review of the clinical trials. CNS Drug Rev 2007;13:137-77
  • Keck PJr, Buffenstein A, Ferguson J, et al. Ziprasidone 40 mg and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: A 4-week placebo-controlled trial. Psychopharmacology 1998;140:173-84
  • Daniel DG, Zimbroff DL, Potkin SG, et al. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Neuropsychopharmacology 1999;20:491-505
  • Arato M, O’Connor R, Meltzer HY, et al. A 1-year, double-blind, placebo-controlled trial of ziprasidone 40, 80 and 160 mg/day in chronic schizophrenia: the Ziprasidone Extended Use in Schizophrenia (ZEUS) study. Int Clin Psychopharmacol 2002;17:207-15
  • Addington DEN, Pantelis C, Dineen M, et al. Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: an 8-week, double-blind, multicenter trial. J Clin Psychiatry 2004;65:1624-33
  • Simpson GM, Weiden P, Pigott T, et al. Six–month, blinded, multicenter contin- uation study of ziprasidone versus olanzapine in schizophrenia. Am J Psychiatry 2006;162:1535-8
  • Kane JM, Khanna S, Rajadhyaksha S, et al. Efficacy and tolerability of ziprasidone in patients with treatment-resistant schizophrenia. Int Clin Psychopharmacol 2006;21:21-8
  • Potkin SG, Keck PEJr, Segal S, et al. Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial. J Clin Psychopharmacol 2005;25:301-10
  • Breier A, Berg PH, Thakore JH, et al. Olanzapine versus ziprasidone: results of a 28-week double-blind study in patients with schizophrenia. Am J Psychiatry 2005;162:1879-87
  • Kinon BJ, Lipkovich I, Edwards SB, et al. A 24-week randomized study of olanzapine versus ziprasidone in the treatment of schizophrenia or schizoaffective disorder in patients with prominent depressive symptoms. J Clin Psychopharmacol 2006;26:157-62
  • Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of second-generation antipsychotics. Arch Gen Psychiatry 2003;60:553-64
  • Manschreck TC, Boshes RA. The CATIE schizophrenia trial: results, impact, controversy. Harv Rev Psychiatry 2007;15:245-58
  • Sauriol L, Laporta M, Edwardes MD, et al. Meta-analysis comparing newer antipsychotic drugs for the treatment of schizophrenia: evaluating the indirect approach. Clin Ther 2001;23:942-56
  • Stroup TS, Lieberman JA, McEvoy JP, et al. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry 2006;163:611-22
  • McEvoy JP, Lieberman JA, Stroup TS, et al. Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry 2006;163:600-10
  • Harvey PD, Sacchetti E, Galluzzo A, et al. A randomized double-blind comparison of ziprasidone vs. clozapine for cognition in patients with schizophrenia selected for resistance or intolerance to previous treatment. Schizophr Res 2008;105:138-43
  • Désaméricq G, Schurhoff F, Meary A. Long-term neurocognitive effects of antipsychotics in schizophrenia: a network meta-analysis. Eur J Clin Pharmacol 2014;70:127-34
  • Asenjo Lobos C, Komossa K, Rummel-Kluge C, et al. Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev 2010(11):CD006633
  • Komossa K, Rummel-Kluge C, Hunger H, et al. Ziprasidone versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev 2009(4):CD006627
  • Vieta E, Günther O, Locklear J, et al. Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol 2011;14:1029-49
  • Grande I, Bernardo M, Bobes J, et al. Antipsychotic switching in bipolar disorders: a systematic review. Int J Neuropsychopharmacol 2014;17:497-507
  • Scott LK, Green R, McCarthy PJ, Conrad SA. Agitation and/or aggression after traumatic brain injury in the pediatric population treated with ziprasidone: clinical article. J Neurosurg Pediatr 2009;3:484-7
  • Vulink NCC, Figee M, Denys D. Review of atypical antipsychotics in anxiety. Eur Neuropsychopharmacol 2011;21:429-49
  • Snyderman SH, Rynn MA, Rickels K. Open-label pilot study of ziprasidone for refractory generalized anxiety disorder. J Clin Psychopharmacol 2005;25:497-9
  • Lohoff FW, Etemad B, Mandos LA, et al. Ziprasidone treatment of refractory generalized anxiety disorder: a placebo-controlled, double-blind study. J Clin Psychopharmacol 2010;30:185-9
  • Wilner KD, Anziano RJ, Johnson AC, et al. The anxiolytic effect of the novel antipsychotic ziprasidone compared with diazepam in subjects anxious before dental surgery. J Clin Psychopharmacol 2002;22:206-10
  • Kellner M, Muhtz C, Wiedemann K. Primary add-on of ziprasidone in sertraline treatment of posttraumatic stress disorder: lessons from a stopped trial? J Clin Psychopharmacol 2010;30:471-3
  • ClinicalTrials.gov. Trial identifier NCT00215150 Geodon for the Treatment of Refractory Social Anxiety Disorder (SAD). National Institutes of Health, Bethesda, MD; 2012. Available from: http://clinicaltrials.gov/ct2/show/NCT00215150?term=NCT00215150&rank=1 [Last accessed 20 February 2014]
  • Harrington CA, English C. Adverse drug events related to ziprasidone: a meta-analysis of randomized, placebo-controlled trials. Pharmacotherapy 2011;31:840-9
  • Gao K, Pappadopulos E, Karayal ON, et al. Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia. J Clin Psychopharmacol 2013;33:425-31
  • Moteshafi H, Stip E. Comparing tolerability profile of quetiapine, risperidone, aripiprazole and ziprasidone in schizophrenia and affective disorders: a meta-analysis. Expert Opin Drug Saf 2012;11:713-32
  • Goff DC, Posever T, Herz L, et al. An exploratory haloperidol-controlled dose-finding study of ziprasidone in hospitalized patients with schizophrenia or schizoaffective disorder. J Clin Psychopharmacol 1998;18:296-304
  • Kahn RS, Fleischhacker WW, Boter H, et al. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet 2008;371:1085-97
  • Gardner DM, Teehan MD. Antipsychotics and their side effects. Cambridge University Press; Cambridge: 2010
  • Seifert HL, Kinon BJ, Tennant CJ, et al. Sexual dysfunction in patients with schizophrenia treated with conventional antipsychotics or risperidone. Neuropsychiatr Dis Treat 2009;5:47-54
  • Montejo AL, Rico-Villademoros F; Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction. Changes in sexual function for outpatients with schizophrenia or other psychotic disorders treated with ziprasidone in clinical practice settings: a 3-month prospective, observational study. J Clin Psychopharmacol 2008;28:568-70
  • Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet 2013;382:951-62
  • Rummel-Kluge C, Komossa K, Schwarz S, et al. Head-to-head comparisons of metabolic side effects of second generation antipsychotics in the treatment of schizophrenia: a systematic review and meta-analysis. Schizophr Res 2010;123:225-33
  • Gutiérrez Fraile M, De La Gándara Martín JJ, Bobes García J. Switching to ziprasidone in the clinical practice setting: an open-label study. Int J Psychiatry Med 2013;45:125-42
  • US Food and Drug Administration, Psychopharmacological Drugs Advisory Committee, Briefing Document for Zeldox Capsules (Ziprasidone HCI). 2000. Available from: http://wwwfdagov/ohrms/dockets/ac/00/backgrd/3619b1a.pdf [Last accessed 20 February 2014]
  • Miceli JJ, Tensfeldt TG, Shiovitz T, et al. Effects of oral ziprasidone and oral haloperidol on QTc interval in patients with schizophrenia or schizoaffective disorder. Pharmacotherapy 2010;30:127-35
  • Straus SM, Kors JA, De Bruin ML, et al. Prolonged QTc interval and risk of sudden cardiac death in a population of older adults. J Am Coll Cardiol 2006;47:362-7
  • Harrigan EP, Miceli JJ, Anziano R, et al. A randomized evaluation of the effects of six antipsychotic agents on QTc, in the absence and presence of metabolic inhibition. J Clin Psychopharmacol 2004;24:62-9
  • Citrome L. A review of the pharmacology, efficacy and tolerability of recently approved and upcoming oral antipsychotics: an evidence-based medicine approach. CNS Drugs 2013;27:879-911
  • Camm AJ, Karayal ON, Meltzer H, et al. Ziprasidone and the corrected QT interval: a comprehensive summary of clinical data. CNS Drugs 2012;26:351-65
  • Geier JL, Karayal ON, Lewis M, et al. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC) Pharmacoepidemiol Drug Saf. 2011;20:1192-8
  • Food and Drug Administration, FDA Drug Safety Communication: abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide). 2011. Available from: http://www.fda.gov/drugs/drugsafety/ucm269086.htm [Last accessed 3 July 2014]
  • Castro VM, Clements CC, Murphy SN, et al. QT interval and antidepressant use: a cross sectional study of electronic health records. BMJ 2013;346:f288
  • Nosè M, Barbui C. Do antidepressants prolong the QT interval? Epidemiol Psychiatr Sci 2014;23:19-20
  • Spina E, De Leon J. Clinically relevant interactions between newer antidepressants and second-generation antipsychotics. Expert Opin Drug Metab Toxicol 2014;10:721-46
  • Kogut C, Crouse EB, Vieweg WVR, et al. Selective serotonin reuptake inhibitors and torsade de pointes: new concepts and new directions derived from a systematic review of case reports. Ther Adv Drug Saf 2013;4:189-98
  • Hiemke C, Baumann P, Bergemann N, et al. AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: update 2011. Pharmacopsychiatry 2011;4:195-235
  • Chermá MD, Reis M, Hägg S, et al. Therapeutic drug monitoring of ziprasidone in a clinical treatment setting. Ther Drug Monit 2008;30:682-8
  • Mercolini L, Protti M, Fulgenzi G, et al. A fast and feasible microextraction by packed sorbent (MEPS) procedure for HPLC analysis of the atypical antipsychotic ziprasidone in human plasma. J Pharm Biomed Anal 2014;88:467-71
  • Mercolini L, Mandrioli R, Protti M, et al. Dried Blood Spot (DBS) testing: a novel approach for the therapeutic drug monitoring of patients treated with ziprasidone. Bioanalysis 2014;6:1487-95
  • Citrome L. A systematic review of meta-analyses of the efficacy of oral atypical antipsychotics for the treatment of adult patients with schizophrenia. Expert Opin Pharmacother 2012;13:1545-73
  • Muscatello MRA, Pandolfo G, Micò U, et al. Augmentation of clozapine with ziprasidone in refractory schizophrenia: a double blind, placebo controlled study. J Clin Psychopharmacol 2014;34:129-33
  • Crespo-Facorro B, Ortiz-Garcia De La Foz V, Mata I, et al. Treatment of first-episode non-affective psychosis: a randomised comparison of aripiprazole, quetiapine and ziprasidone over 1 year. Psychopharmacology (Berl) 2014;231:357-66
  • Findling RL, Çavuş I, Pappadopulos E, et al. Ziprasidone in adolescents with schizophrenia: results from a placebo controlled efficacy and long-term open-extension study. J Child Adolesc Psychopharmacol 2013;23:531-44
  • Johnsen E, Sinkeviciute I, Løberg E-M, et al. Hallucinations in acutely admitted patients with psychosis, and effectiveness of risperidone, olanzapine, quetiapine, and ziprasidone: a pragmatic, randomised study. BMC Psychiatry 2013;13:art241
  • Goff DC, McEvoy JP, Citrome L, et al. High-dose oral ziprasidone versus conventional dosing in schizophrenia patients with residual symptoms: the ZEBRAS study. J Clin Psychopharmacol 2013;33:485-90
  • Park S, Yi KK, Kim M-S, Hong JP. Effects of ziprasidone and olanzapine on body composition and metabolic parameters: an open label comparative pilot study. Behav Brain Funct 2013;9:art27
  • Crespo-Facorro B, Ortiz-García de la Foz V, Mata I, et al. Aripiprazole, ziprasidone and quetiapine in the treatment of first-episode nonaffective psychosis: a 12-week trial. Schizophr Res 2013;147:375-82
  • Johnsen E, Jørgensen HA, Kroken RA, Løberg E-M. Neurocognitive effectiveness of quetiapine, olanzapine, risperidone, and ziprasidone: a pragmatic, randomised trial. Eur Psychiatry 2013;28:174-84
  • Ou J-J, Xu Y, Chen H-H, et al. Comparison of metabolic effects of ziprasidone versus olanzapine treatment in patients with first-episode schizophrenia. Psychopharmacology (Berl) 2013;225:627-35
  • San L, Arranz B, Perez V, et al. One-year, randomised, open trial comparing olanzapine, quetiapine, risperidone and ziprasidone effectiveness in antipsychotic-naive patients with a first-episode psychosis. Psychiatry Res 2012;200:693-701
  • Alvarez E, Bernardo M, Casares JRG, Montejo AL. Ziprasidone versus olanzapine in the weight gain associated with the treatment of schizophrenia: a six-month double blind randomised parallel group study. Eur J Psychiatry 2012;26:248-59
  • Chen Y, Bobo WV, Watts K, et al. Comparative effectiveness of switching antipsychotic drug treatment to aripiprazole or ziprasidone for improving metabolic profile and atherogenic dyslipidemia: a 12-month, prospective, open label study. J Psychopharmacol 2012;26:1201-10
  • Zhao T, Park T-W, Yang J-C, et al. Efficacy and safety of ziprasidone in the treatment of first-episode psychosis: an 8-week, open label, multicenter trial. Int Clin Psychopharmacol 2012;27:184-90
  • Mencacci C. Efficacy and tolerability of switching to ziprasidone in Italian patients with acute exacerbation of schizophrenia: an open label trial. Pharmacopsychiatry 2012;45:236-40
  • Li Y-M, Zhao J-P, Ou J-J, Wu R-R. Efficacy and tolerability of ziprasidone vs olanzapine in naive first-episode schizophrenia: a 6-week, randomised, open label, flexible-dose study. Pharmacopsychiatry 2012;45:177-81
  • Potkin SG, Ogasa M, Cucchiaro J, Loebel A. Double blind comparison of the safety and efficacy of lurasidone and ziprasidone in clinically stable outpatients with schizophrenia or schizoaffective disorder. Schizophr Res 2011;132:101-7
  • Kjelby E, Jørgensen HA, Kroken RA, et al. Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomised trial. BMC Psychiatry 2011;11:art145
  • Mautone A, Scarone S. Transition from ziprasidone i.m. to oral formulation in agitated patients with acute exacerbation of schizophrenia: an open trial. Pharmacopsychiatry 2011;44:173-8
  • Harvey PD, Ogasa M, Cucchiaro J, et al. Performance and interview-based assessments of cognitive change in a randomised, double blind comparison of lurasidone vs. ziprasidone. Schizophr Res 2011;127:188-94
  • Karayal ON, Glue P, Bachinsky M, et al. Switching from quetiapine to ziprasidone: a sixteen-week, open label, multicenter study evaluating the effectiveness and safety of ziprasidone in outpatient subjects with Schizophrenia or schizoaffective disorder. J Psychiatr Pract 2011;17:100-9
  • Grootens KP, Van Veelen NMJ, Peuskens J, et al. Ziprasidone vs olanzapine in recent-onset schizophrenia and schizoaffective disorder: results of an 8-week double blind randomised controlled trial. Schizophr Bull 2011;37:352-61
  • Grootens KP, van Veelen NMJ, Sitskoorn MM, et al. Effects on cognitive functioning after olanzapine-ziprasidone crossover in recent-onset schizophrenia. Eur Neuropsychopharmacol 2011;20:907-12
  • Stahl SM, Malla A, Newcomer JW, et al. A post hoc analysis of negative symptoms and psychosocial function in patients with schizophrenia: a 40-week randomised, double blind study of ziprasidone versus haloperidol followed by a 3-year double blind extension trial. J Clin Psychopharmacol 2010;30:425-30
  • van Veelen NMJ, Grootens KP, Peuskens J, et al. Short term neurocognitive effects of treatment with ziprasidone and olanzapine in recent onset schizophrenia. Schizophr Res 2010;120:191-8
  • Kim S-W, Shin I-S, Kim J-M, et al. Effectiveness of switching from aripiprazole to ziprasidone in patients with schizophrenia. Clin Neuropharmacol 2010;33:121-5
  • Johnsen E, Kroken RA, Wentzel-Larsen T, Jørgensen HA. Effectiveness of second-generation antipsychotics: a naturalistic, randomised comparison of olanzapine, quetiapine, risperidone, and ziprasidone. BMC Psychiatry 2010;10:art26
  • Lublin H, Haug H-J, Koponen H, et al. Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open label, multicentre clinical trial. World J Biol Psychiatry 2009;10:710-18
  • Harvey PD, Pappadopulos E, Lombardo I, Kremer CM. Reduction of functional disability with atypical antipsychotic treatment: a randomised long term comparison of ziprasidone and haloperidol. Schizophr Res 2009;115:24-9
  • Potkin SG, Weiden PJ, Loebel AD, et al. Remission in schizophrenia: 196-week, double blind treatment with ziprasidone vs. haloperidol. Int J Neuropsychoph 2009;12:1233-48
  • Henderson DC, Fan X, Copeland PM, et al. Ziprasidone as an adjuvant for clozapine- or olanzapine-associated medical morbidity in chronic schizophrenia. Hum Psychopharmacol 2009;24:225-32
  • Alptekin K, Hafez J, Brook S, et al. Efficacy and tolerability of switching to ziprasidone from olanzapine, risperidone or haloperidol: an international, multicenter study. Int Clin Psychopharmacol 2009;24:229-38
  • Sacchetti E, Galluzzo A, Valsecchi P, et al. Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: the MOZART study. Schizophr Res 2009;113:112-21
  • Zink M, Kuwilsky A, Krumm B, Dressing H. Efficacy and tolerability of ziprasidone versus risperidone as augmentation in patients partially responsive to clozapine: a randomised controlled clinical trial. J Psychopharmacol 2009;23:305-14
  • Díaz-Marsá M, Sánchez S, Rico-Villademoros F. Effectiveness and tolerability of oral ziprasidone in psychiatric inpatients with an acute exacerbation of schizophrenia or schizoaffective disorder: a multicenter, prospective, and naturalistic study. J Clin Psychiatry 2009;70:509-17
  • Addington DE, Labelle A, Kulkarni J, et al. A comparison of ziprasidone and risperidone in the long-term treatment of schizophrenia: a 44-week, double blind, continuation study. Can J Psychiatry 2009;54:46-54
  • Harvey PD, Sacchetti E, Galluzzo A, et al. A randomised double blind comparison of ziprasidone vs. clozapine for cognition in patients with schizophrenia selected for resistance or intolerance to previous treatment. Schizophr Res 2008;105:138-43
  • Simpson GM, O’Gorman CJ, Loebel A, Yang R. Long-term improvement in efficacy and safety after switching to ziprasidone in stable outpatients with schizophrenia. CNS Spectr 2008;13:898-905
  • Gibel A, Ritsner MS. Neurocognitive effects of ziprasidone and related factors in patients with chronic schizophrenia undergoing usual care: a 12-month, open label, flexible-dose, naturalistic observational trial. Clin Neuropharmacol 2008;31:204-20
  • Rossi A, Vita A, Tiradritti P, Romeo F. Assessment of clinical and metabolic status, and subjective well-being, in schizophrenic patients switched from typical and atypical antipsychotics to ziprasidone. Int Clin Psychopharmacol 2008;23:216-22
  • Zimbroff D, Warrington L, Loebel A, et al. Comparison of ziprasidone and aripiprazole in acutely ill patients with schizophrenia or schizoaffective disorder: a randomised, double blind, 4-week study. Int Clin Psychopharmacol 2007;22:363-70
  • Ratner Y, Gibel A, Yorkov V, Ritsner MS. Effectiveness, safety, and tolerability of ziprasidone for treating schizophrenia patients undergoing usual care: a 12-month, open label, flexible-dose, naturalistic observational trial. Prog Neuropsychopharmacol Biol Psychiatry 2007;31:1401-9
  • Ritsner MS, Yorkov V, Ratner Y, et al. The effectiveness of ziprasidone in treating impaired quality of life in schizophrenia: a 12-month, open label, flexible-dose, naturalistic observational study of patients undergoing usual care. Prog Neuropsychopharmacol Biol Psychiatry 2007;31:1470-7
  • Loebel AD, Khanna S, Rajadhyaksha S, et al. Ziprasidone in treatment-resistant schizophrenia: a 52-week, open label continuation study. J Clin Psychiatry 2007;68:1333-8
  • Arango C, Gómez-Beneyto M, Brenlla J, et al. A 6-month prospective, observational, naturalistic, uncontrolled study to evaluate the effectiveness and tolerability of oral ziprasidone in patients with schizophrenia. Eur Neuropsychopharmacol 2007;17:456-63
  • Kudla D, Lambert M, Domin S, et al. Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: results of a multi-centre observational trial. Eur Psychiatry 2007;22:195-202
  • Montes JM, Rodriguez JL, Balbo E, et al. Improvement in antipsychotic-related metabolic disturbances in patients with schizophrenia switched to ziprasidone. Prog Neuropsychopharmacol Biol Psychiatry 2007;31:383-8
  • Fagerlund B, Søholm B, Fink-Jensen A, et al. Effects of donepezil adjunctive treatment to ziprasidone on cognitive deficits in schizophrenia: a double blind, placebo controlled study. Clin Neuropharmacol 2007;30:3-12
  • Suppes T, McElroy SL, Sheehan DV, et al. A randomised, double blind, placebo controlled study of ziprasidone monotherapy in bipolar disorder with co-occurring lifetime panic or generalized anxiety disorder. J Clin Psychiatry 2014;75:77-84
  • Findling RL, Çavuş I, Pappadopulos E, et al. Efficacy, long-term safety, and tolerability of Ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol 2013;23:545-57
  • Lee H-B, Yoon B-H, Kwon Y-J, et al. The efficacy and safety of switching to ziprasidone from olanzapine in patients with bipolar I disorder: an 8-week, multicenter, open label study. Clin Drug Investig 2013;33:743-53
  • Bowden CL, Karayal ON, Schwartz JH, et al. Characterizing relapse prevention in bipolar disorder with adjunctive ziprasidone: clinical and methodological implications. J Affect Disord 2013;144:171-5
  • Papakostas GI, Vitolo OV, Ishak WW, et al. A 12-week, randomised, double blind, placebo controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. J Clin Psychiatry 2012;73:1541-7
  • Sachs GS, Vanderburg DG, Karayal ON, et al. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomised, double blind, placebo controlled trial. J Clin Psychiatry 2012;73:1412-19
  • Pae C-U, Masand PS, Mandel FS, O’Gorman C. Achieving and sustaining remission in bipolar I disorder with ziprasidone: a post hoc analysis of a 24-week, double blind, placebo controlled study. Clin Drug Investig 2012;32:747-54
  • Patkar A, Gilmer W, Pae C-U, et al. A 6 week randomised double blind placebo controlled trial of ziprasidone for the acute depressive mixed state. PLoS One 2012;7:e34757
  • Pae C-U, Patkar AA, Gilmer W, et al. Predictors of response to ziprasidone: results from a 6-week randomised double blind, placebo controlled trial for acute depressive mixed state. Pharmacopsychiatry 2012;45:152-5
  • Sachs GS, Ice KS, Chappell PB, et al. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomised, double blind, placebo controlled trial. J Clin Psychiatry 2011;72:1413-22
  • Wang PW, Hill SJ, Childers ME, et al. Open adjunctive ziprasidone associated with weight loss in obese and overweight bipolar disorder patients. J Psychiatr Res 2011;45:1128-32
  • Lohoff FW, Etemad B, Mandos LA, et al. Ziprasidone treatment of refractory generalized anxiety disorder: a placebo controlled, double blind study. J Clin Psychopharmacol 2010;30:185-9
  • Vieta E, Ramey T, Keller D, et al. Ziprasidone in the treatment of acute mania: a 12-week, placebo controlled, haloperidol-referenced study. J Psychopharmacol 2010;24:547-58
  • Bowden CL, Vieta E, Ice KS, et al. Ziprasidone plus a mood stabilizer in subjects with bipolar i disorder: a 6-month, randomised, placebo controlled, double blind trial. J Clin Psychiatry 2010;71:130-7
  • Liebowitz MR, Salmán E, Mech A, et al. Ziprasidone monotherapy in bipolar II depression: an open trial. J Affect Disord 2009;118:205-8
  • Keck PEJr, Versiani M, Warrington L, et al. Long-term safety and efficacy of ziprasidone in subpopulations of patients with bipolar mania. J Clin Psychiatry 2009;70:844-51
  • Pascual JC, Soler J, Puigdemont D, et al. Ziprasidone in the treatment of borderline personality disorder: a double blind, placebo controlled, randomised study. J Clin Psychiatry 2008;69:603-60
  • Biederman J, Mick E, Spencer T, et al. A prospective open label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder. Bipolar Disord 2007;9:888-94
  • Malone RP, Delaney MA, Hyman SB, Cater JR. Ziprasidone in adolescents with autism: an open label pilot study. J Child Adolesc Psychopharmacol 2007;17:779-90
  • Dunner DL, Amsterdam JD, Shelton RC, et al. Efficacy and tolerability of adjunctive ziprasidone in treatment-resistant depression: a randomised, open label, pilot study. J Clin Psychiatry 2007;68:1071-7

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.