Asenapine for the treatment of manic and mixed episodes associated with bipolar I disorder: from clinical research to clinical practice

Bibliography

• Judd LL, Akiskal HS, Schettler PJ, The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry 2002;59(6):530-7
   PubMed Web of Science ®Google Scholar
• Keitner GI, Solomon DA, Ryan CE, Prodromal and residual symptoms in bipolar I disorder. Compr Psychiatry 1996;37(5):362-7
   PubMed Web of Science ®Google Scholar
• Solomon DA, Leon AC, Coryell WH, Longitudinal course of bipolar I disorder: duration of mood episodes. Arch Gen Psychiatry 2010;67(4):339-47
   PubMed Web of Science ®Google Scholar
• Kaya E, Aydemir O, Selcuki D. Residual symptoms in bipolar disorder: the effect of the last episode after remission. Prog Neuropsychopharmacol Biol Psychiatry 2007;31(7):1387-92
   PubMed Web of Science ®Google Scholar
• Kleinman L, Lowin A, Flood E, Costs of bipolar disorder. Pharmacoeconomics 2003;21(9):601-22; Review
   PubMed Web of Science ®Google Scholar
• Fagiolini A, Chengappa KN, Soreca I, Chang J. Bipolar disorder and the metabolic syndrome: causal factors, psychiatric outcomes and economic burden. CNS Drugs 2008;22(8):655-69; Review
   PubMed Web of Science ®Google Scholar
• Centorrino F, Mark TL, Talamo A, Health and economic burden of metabolic comorbidity among individuals with bipolar disorder. J Clin Psychopharmacol 2009;29(6):595-600
   PubMed Web of Science ®Google Scholar
• van Winkel R, De Hert M, Wampers M, Major changes in glucose metabolism, including new-onset diabetes, within 3 months after initiation of or switch to atypical antipsychotic medication in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry 2008;69(3):472-9
   PubMed Web of Science ®Google Scholar
• Lieberman JA III. Managing anticholinergic side effects. Prim Care Companion J Clin Psychiatry 2004;6(Suppl 2):20-3
   PubMedGoogle Scholar
• Ray WA, Chung CP, Murray KT, Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med 2009;360(3):225-35
   PubMed Web of Science ®Google Scholar
• Weiner M, Warren L, Fiedorowicz JG. Cardiovascular morbidity and mortality in bipolar disorder. Ann Clin Psychiatry 2011;23:40-7
   PubMed Web of Science ®Google Scholar
• Meltzer HY, Bonaccorso S, Bobo WV, A 12-month randomized, open-label study of the metabolic effects of olanzapine and risperidone in psychotic patients: influence of valproic acid augmentation. J Clin Psychiatry 2011;72(12):1602-10
   PubMed Web of Science ®Google Scholar
• Citrome L. Asenapine for schizophrenia and bipolar disorder: a review of the efficacy and safety profile for this newly approved sublingually absorbed second-generation antipsychotic. Int J Clin Pract 2009;63(12):1762-84
   PubMed Web of Science ®Google Scholar
• FDA Psychopharmacologic Drugs Advisory Committee Meeting, SAPHRIS® (asenapine) Sublingual Tablets (NDA 22-117). 2009; Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173876.pdf [ [Accessed 13 October 2012]; Saphris package insert. Available from: http://www.spfiles.com/pisaphrisv1.pdf [ [Accessed October 2012]
   Google Scholar
• Hulskotte E, Spaans E, Timmer C, Effects of water intake and smoking on absorption of sublingually administered asenapine. Poster presented at the 110th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT); 18 – 21 March 2009; Washington, USA
   Google Scholar
• Shahid M, Walker GB, Zorn SH, Wong EH. Asenapine: a novel psychopharmacologic agent with a unique human receptor signature. J Psychopharmacol 2009;23(1):65-73
   PubMed Web of Science ®Google Scholar
• Ghanbari R, El Mansari M, Shahid M, Blier P. Electrophysiological characterization of the effects of asenapine at 5-HT(1A), 5-HT(2A), alpha(2)-adrenergic and D(2) receptors in the rat brain. Eur Neuropsychopharmacol 2009;19(3):177-87
   PubMed Web of Science ®Google Scholar
• Tarazi FI, Moran-Gates T, Wong EH, Differential regional and dose-related effects of asenapine on dopamine receptor subtypes. Psychopharmacology (Berl) 2008;198(1):103-11
   PubMed Web of Science ®Google Scholar
• Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patient's clinical profile. CNS Spectr 2004;9(10 Suppl 11):6-14
   PubMed Web of Science ®Google Scholar
• Kroeze WK, Hufeisen SJ, Popadak BA, H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacology 2003;28(3):519-26
   PubMed Web of Science ®Google Scholar
• Reynolds GP. Receptor mechanisms of antipsychotic drug action in bipolar disorder-focus on asenapine. Ther Adv Psychopharmacol 2011;1(6):197-204
   PubMedGoogle Scholar
• Tarazi FI, Choi YK, Gardner M, Asenapine exerts distinctive regional effects on ionotropic glutamate receptor subtypes in rat brain. Synapse 2009;63(5):413-20
   PubMed Web of Science ®Google Scholar
• Tarazi FI, Moran-Gates T, Wong EH, Asenapine induces differential regional effects on serotonin receptor subtypes. J Psychopharmacol 2010;24(3):341-8
   PubMed Web of Science ®Google Scholar
• Choi YK, Wong EH, Henry B, Repeated effects of asenapine on adrenergic and cholinergic muscarinic receptors. Int J Neuropsychopharmacol 2010;13(3):405-10
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Cohen M, Zhao J, A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord 2009;11(7):673-86
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Cohen M, Zhao J, Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord 2010;122(1-2):27-38
   PubMed Web of Science ®Google Scholar
• Szegedi A, Calabrese JR, Stet L, Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol 2012;32(1):46-55
   PubMed Web of Science ®Google Scholar
• Szegedi A, Zhao J, van Willigenburg A, Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials. BMC Psychiatry 2011;11:101
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Cohen M, Zhao J, Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord 2009;11(8):815-26
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Cohen M, Zhao J, Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord 2010;126(3):358-65
   PubMed Web of Science ®Google Scholar
• Chapel S, Hutmacher MM, Haig G, Exposure-response analysis in patients with schizophrenia to assess the effect of asenapine on QTc prolongation. J Clin Pharmacol 2009;49(11):1297-308
   PubMed Web of Science ®Google Scholar
• Cazorla P, Mackle M, Zhao J, Safety and tolerability of switching to asenapine from other antipsychotic agents: pooled results from two randomized multicenter trials in stable patients with persistent negative symptoms in schizophrenia. Neuropsychiatr Dis Treat 2012;8:247-57
   PubMed Web of Science ®Google Scholar
• Baruch Y, Tadger S, Plopski I, Barak Y. Asenapine for elderly bipolar manic patients. J Affect Disord 2012; Epub ahead of print
   PubMed Web of Science ®Google Scholar
• Keck PE Jr, Marcus R, Tourkodimitris S, Aripiprazole Study Group. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 2003;160(9):1651-8
   PubMed Web of Science ®Google Scholar
• Potkin SG, Keck PE Jr, Segal S, Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial. J Clin Psychopharmacol 2005;25(4):301-10
   PubMed Web of Science ®Google Scholar
• Sachs G, Sanchez R, Marcus R, Aripiprazole Study Group. Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study. J Psychopharmacol 2006;20(4):536-46
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Brecher M, Paulsson B, Quetiapine or haloperidol as monotherapy for bipolar mania–a 12-week, double-blind, randomised, parallel-group, placebo-controlled trial. Eur Neuropsychopharmacol 2005;15(5):573-85
   PubMed Web of Science ®Google Scholar
• Bowden CL, Grunze H, Mullen J, A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. J Clin Psychiatry 2005;66(1):111-21
   PubMed Web of Science ®Google Scholar
• Hirschfeld RM, Keck PE Jr, Kramer M, Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry 2004;161(6):1057-65
   PubMed Web of Science ®Google Scholar
• Vieta E, Bourin M, Sanchez R, Aripiprazole Study Group. Effectiveness of aripiprazole v. haloperidol in acute bipolar mania: double-blind, randomised, comparative 12-week trial. Br J Psychiatry 2005;187:235-42
   PubMed Web of Science ®Google Scholar
• Tohen M, Goldberg JF, Gonzalez-Pinto Arrillaga AM, A 12-week, double-blind comparison of olanzapine vs haloperidol in the treatment of acute mania. Arch Gen Psychiatry 2003;60(12):1218-26
   PubMed Web of Science ®Google Scholar
• Smulevich AB, Khanna S, Eerdekens M, Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. Eur Neuropsychopharmacol 2005;15(1):75-84
   PubMed Web of Science ®Google Scholar
• Cipriani A, Barbui C, Salanti G, Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet 2011;378(9799):1306-15
   PubMed Web of Science ®Google Scholar
• Fagiolini A, Frank E, Houck PR, Prevalence of obesity and weight change during treatment in patients with bipolar I disorder. J Clin Psychiatry 2002;63(6):528-33
   PubMed Web of Science ®Google Scholar
• Fagiolini A, Kupfer DJ, Houck PR, Obesity as a correlate of outcome in patients with bipolar I disorder. Am J Psychiatry 2003;160(1):112-17
   PubMed Web of Science ®Google Scholar
• Fagiolini A, Frank E, Scott JA, Metabolic syndrome in bipolar disorder: findings from the Bipolar Disorder Center for Pennsylvanians. Bipolar Disord 2005;7(5):424-30
   PubMed Web of Science ®Google Scholar
• Fagiolini A, Frank E, Turkin S, Metabolic syndrome in patients with bipolar disorder. J Clin Psychiatry 2008;69(4):678-9
   PubMed Web of Science ®Google Scholar
• Fagiolini A, Goracci A. The effects of undertreated chronic medical illnesses in patients with severe mental disorders. J Clin Psychiatry 2009;70(Suppl 3):22-9
   PubMed Web of Science ®Google Scholar
• Grunze H, Vieta E, Goodwin GM, The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2009 on the treatment of acute mania. World J Biol Psychiatry 2009;10(2):85-116
   PubMed Web of Science ®Google Scholar
• Lieberman JA, Stroup TS, McEvoy JP, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353(12):1209-23
   PubMed Web of Science ®Google Scholar
• Taylor V, MacQueen G. Associations between bipolar disorder and metabolic syndrome: a review. J Clin Psychiatry 2006;67(7):1034-41
   PubMed Web of Science ®Google Scholar
• Perlis RH, Welge JA, Vornik LA, Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry 2006;67(4):509-16; Review
   PubMed Web of Science ®Google Scholar
• Giorgetti M, Tecott LH. Contributions of 5-HT(2C) receptors to multiple actions of central serotonin systems. Eur J Pharmacol 2004;488(1-3):1-9; Review
   PubMed Web of Science ®Google Scholar
• Blier P, Szabo ST. Potential mechanisms of action of atypical antipsychotic medications in treatment-resistant depression and anxiety. J Clin Psychiatry 2005;66(Suppl 8):30-40; Review
   PubMed Web of Science ®Google Scholar
• Guscott M, Bristow LJ, Hadingham K, Genetic knockout and pharmacological blockade studies of the 5-HT7 receptor suggest therapeutic potential in depression. Neuropharmacology 2005;48(4):492-502
   PubMed Web of Science ®Google Scholar
• Franberg O, Marcus MM, Ivanov V, Asenapine elevates cortical dopamine, noradrenaline and serotonin release. Evidence for activation of cortical and subcortical dopamine systems by different mechanisms. Psychopharmacology (Berl) 2009;204(2):251-64
   PubMed Web of Science ®Google Scholar
• Marston HM, Young JW, Martin FD, Asenapine effects in animal models of psychosis and cognitive function. Psychopharmacology (Berl) 2009;206(4):699-714
   PubMed Web of Science ®Google Scholar
• Kukopulos A, Reginaldi D, Laddomada P, Course of the manic-depressive cycle and changes caused by treatment. Pharmakopsychiatr Neuropsychopharmakol 1980;13(4):156-67
   PubMedGoogle Scholar
• Tohen M, Vieta E, Calabrese J, Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 2003;60(11):1079-88
   PubMed Web of Science ®Google Scholar
• Tohen M, Ketter TA, Zarate CA, Olanzapine versus divalproex sodium for the treatment of acute mania and maintenance of remission: a 47-week study. Am J Psychiatry 2003;160(7):1263-71
   PubMed Web of Science ®Google Scholar
• Tohen M, Greil W, Calabrese JR, Olanzapine versus lithium in the maintenance treatment of bipolar disorder: a 12-month, randomized, double-blind, controlled clinical trial. Am J Psychiatry 2005;162(7):1281-90
   PubMed Web of Science ®Google Scholar
• Tohen M, Calabrese JR, Sachs GS, Randomized, placebo-controlled trial of olanzapine as maintenance therapy in patients with bipolar I disorder responding to acute treatment with olanzapine. Am J Psychiatry 2006;163(2):247-56
   PubMed Web of Science ®Google Scholar
• Prowse A, Zhao J, Ha X, Early improvement predicts later outcome in manic or mixed episodes associated with bipolar I disorder: post hoc analyses of asenapine studies. Int Clin Psychophar 2011;26:e47
   Google Scholar
• Gao K, Ganocy SJ, Gajwani P, A review of sensitivity and tolerability of antipsychotics in patients with bipolar disorder or schizophrenia: focus on somnolence. J Clin Psychiatry 2008;69(2):302-9
   PubMed Web of Science ®Google Scholar
• Edwards SJ, Smith CJ. Tolerability of atypical antipsychotics in the treatment of schizophrenia and bipolar disorder: a mixed treatment comparison of randomised controlled trials. Clin Ther 2009;31:1345-59
   PubMed Web of Science ®Google Scholar
• Scherk H, Pajonk FG, Leucht S. Second-generation antipsychotic agents in the treatment of acute mania: a systematic review and meta-analysis of randomized controlled trials. Arch Gen Psychiatry 2007;64(4):442-55
   PubMed Web of Science ®Google Scholar