Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: Results of a 12-week core study and 40-week extension

Journal of Clinical Psychopharmacology

Volumn 32, Issue 1, 2012, Pages 46-55

  Szegedi, Armin ^a   Calabrese, Joseph R ^b   Stet, Let ^c   MacKle, Mary ^a   Zhao, Jun ^a   Panagides, John ^d  

^a MERCK RESEARCH LABORATORIES   (United States)

^b CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c NV ORGANON   (Netherlands)

^d Now Merck ^*  (United States)

Author keywords

asenapine; bipolar disorder; lithium; mania; valproate

Indexed keywords

ASENAPINE; LITHIUM; PLACEBO; VALPROIC ACID;

ADULT; AGED; AGITATION; AKATHISIA; AKINESIA; ANXIETY; ARTICLE; BACKACHE; BIPOLAR I DISORDER; CLINICAL GLOBAL IMPRESSION SCALE; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSKINESIA; DYSTONIA; EXTRAPYRAMIDAL SYNDROME; FEMALE; FEVER; HEADACHE; HUMAN; HYPESTHESIA; INSOMNIA; IRRITABILITY; LARYNX PAIN; MAJOR CLINICAL STUDY; MALE; MANIA; MONOTHERAPY; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; MYALGIA; NAUSEA; PARKINSONISM; PRIORITY JOURNAL; PSYCHOMOTOR DISORDER; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; SEDATION; SIDE EFFECT; SOMNOLENCE; SORE THROAT; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; TREMOR; VOMITING; WEIGHT GAIN; XEROSTOMIA; YOUNG MANIA RATING SCALE;

ACUTE DISEASE; ADULT; AFFECT; ANTICONVULSANTS; ANTIMANIC AGENTS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HETEROCYCLIC COMPOUNDS WITH 4 OR MORE RINGS; HUMANS; LITHIUM CARBONATE; MALE; MIDDLE AGED; PSYCHIATRIC STATUS RATING SCALES; VALPROIC ACID; YOUNG ADULT;

EID: 84855345812     PISSN: 02710749     EISSN: 1533712X     Source Type: Journal    
DOI: 10.1097/JCP.0b013e31823f872f     Document Type: Article

References (27)

1. Kessler RC, Chiu WT, Demler O, et al. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):617-627. (Pubitemid 40973437)
2. Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007;64(5):543-552. (Pubitemid 46718287)
3. Ketter TA. Diagnostic features, prevalence, and impact of bipolar disorder. J Clin Psychiatry. 2010;71(6):e14.
4. McIntyre RS, Muzina DJ, Kemp DE, et al. Bipolar disorder and suicide: research synthesis and clinical translation. Curr Psychiatry Rep. 2008;10(1):66-72. (Pubitemid 351266372)
5. Hirschfeld RMA, Bowden CL, Gitlin MJ, et al. Practice Guidelines for the Treatment of Patients With Bipolar Disorder. Second Edition. 2002. Available at: http://www.psychiatryonline.com/pracGuide/loadGuidelinePdf.aspx?file=Bipolar2e- Inactivated-04-16-09. Accessed July 12, 2010.
6. Grunze H, Kasper S, Goodwin G, et al. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders, part II: treatment of mania. World J Biol Psychiatry. 2003;4(1):5-13.
7. Yatham LN, Kennedy SH, O'Donovan C, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: update 2007. Bipolar Disord. 2006;8(6):721-739. (Pubitemid 44824712)
8. Tamayo JM, Zarate CA Jr, Vieta E, et al. Level of response and safety of pharmacological monotherapy in the treatment of acute bipolar I disorder phases: a systematic review and meta-analysis. Int J Neuropsychopharmacol. 2010;13(6):813-832.
9. Gajwani P, Kemp DE, Muzina DJ, et al. Acute treatment of mania: an update on new medications. Curr Psychiatry Rep. 2006;8(6):504-509. (Pubitemid 46017241)
10. 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(4):509-516. (Pubitemid 43764227)
11. 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):442-455. (Pubitemid 46556468)
12. Saphris\ (asenapine sublingual tablets). Full Prescribing Information, Schering Corporation, a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ. 2010.
13. European Medicines Agency. Sycrest asenapine. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/ 001177/human-med-001379.jsp&murl=menus/medicines/medicines.jsp&mid= WC0b01ac058001d125&jsenabled=true. Accessed September 28, 2010.
14. Shahid M, Walker GB, Zorn SH, et al. Asenapine: a novel psychopharmacologic agent with a unique human receptor signature. J Psychopharmacol. 2009;23(1):65-73.
15. McIntyre RS, Cohen M, Zhao J, et al. 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.
16. McIntyre RS, Cohen M, Zhao J, et al. 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):673-686.
17. McIntyre RS, Cohen M, Zhao J, et al. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009;11(8):815-826.
18. Tohen M, Frank E, Bowden CL, et al. The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Bipolar Disord. 2009;11(5):453-473.
19. 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(7):1146-1154. (Pubitemid 34743254)
20. 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(3):213-223. (Pubitemid 38702297)
21. Tohen M, Chengappa KN, Suppes T, et al. Efficacy of olanzapine in combination with valproate or lithium in the treatment of mania in patients partially nonresponsive to valproate or lithium monotherapy. Arch Gen Psychiatry. 2002;59(1):62-69. (Pubitemid 34044408)
22. Yatham LN, Grossman F, Augustyns I, et al. Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial. Br J Psychiatry. 2003;182:141-147. (Pubitemid 36177237)
23. Szegedi A, Verweij P, van Duijnhoven W, et al. Meta-analysis of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other atypical antipsychotics. Eur Psychiatry. 2011;26(suppl 1):1511.
24. Tondo L, Isacsson G, Baldessarini R. Suicidal behaviour in bipolar disorder: risk and prevention. CNS Drugs. 2003;17(7):491-511. (Pubitemid 36693704)
25. Baldessarini RJ, Vieta E, Calabrese JR, et al. Bipolar depression: overview and commentary. Harv Rev Psychiatry. 2010;18(3):143-157.
26. McIntyre RS, Cohen M, Zhao J, et al. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010;126(3):358-365.
27. Chapel S, Hutmacher MM, Haig G, et al. Exposure-response analysis in patients with schizophrenia to assess the effect of asenapine on QTc prolongation. J Clin Pharmacol. 2009;49(11):1297-1308.