Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: The SOURCE study results

BMC Psychiatry

Volumn 11, Issue , 2011, Pages

  Macfadden, Wayne ^a   DeSouza, Cherilyn ^b   Crivera, Concetta ^a   Kozma, Chris M ^c   Dirani, Riad D ^a   Mao, Lian ^d   Rodriguez, Stephen C ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c UNIVERSITY OF SOUTH CAROLINA   (United States)

^d JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LONG ACTING DRUG; RISPERIDONE;

ADULT; AFRICAN AMERICAN; ANXIETY DISORDER; ARTICLE; CAUCASIAN; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL GLOBAL IMPRESSION SCALE; DEPRESSION; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEALTH STATUS; HEART FAILURE; HUMAN; INFLUENZA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PROSPECTIVE STUDY; SCHIZOPHRENIA; SHORT FORM 36; SUICIDAL IDEATION; ADOLESCENT; AGED; CLINICAL TRIAL; DELAYED RELEASE FORMULATION; MIDDLE AGED; PSYCHOLOGICAL ASPECT; PSYCHOLOGICAL RATING SCALE; QUALITY OF LIFE; RECURRENT DISEASE; STATISTICS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; DELAYED-ACTION PREPARATIONS; FEMALE; HEALTH STATUS; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PSYCHIATRIC STATUS RATING SCALES; QUALITY OF LIFE; RECURRENCE; RISPERIDONE; SCHIZOPHRENIA;

EID: 80053959895     PISSN: None     EISSN: 1471244X     Source Type: Journal    
DOI: 10.1186/1471-244X-11-167     Document Type: Article

References (45)

1. Perälä J, Suvisaari J, Saarni SI, Kuoppasalmi K, Isometsä E, Pirkola S, Partonen T, Tuulio-Henriksson A, Hintikka J, Kieseppä T, Härkänen T, Koskinen S, Lönnqvist J. Lifetime prevalence of psychotic and bipolar I disorders in a general population. Arch Gen Psychiatry 2007, 64:19-28. 10.1001/archpsyc.64.1.19, 17199051.
2. Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, Moulis M, Aggarwal J. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry 2005, 66(9):1122-1129. 10.4088/JCP.v66n0906, 16187769.
3. Buckley PR. Treatment of schizophrenia: let's talk dollars and sense. Am J Manag Care 1998, 4:369-383.
4. Kane JM. Strategies for improving compliance in treatment of schizophrenia by using a long-acting formulation of an antipsychotic: clinical studies. J Clin Psychiatry 2003, 64(Suppl 16):34-40.
5. McEvoy JP. Risks versus benefits of different types of long-acting injectable antipsychotics. J Clin Psychiatry 2006, 67(Suppl 5):15-18.
6. Adams CE, Fenton MK, Quraishi S, David AS. Systematic meta-review of depot antipsychotic drugs for people with schizophrenia. Br J Psychiatry 2001, 179:290-299. 10.1192/bjp.179.4.290, 11581108.
7. Schooler NR. Relapse and rehospitalization: comparing oral and depot antipsychotics. J Clin Psychiatry 2003, 64(Suppl 16):14-17.
8. Leucht C, Heres S, Kane JM, Kissling W, Davis JM, Leucht S. Oral versus depot antipsychotic drugs for schizophrenia-A critical systematic review and meta-analysis of randomised long-term trials. Schizophr Res 2011, 127:83-92. 10.1016/j.schres.2010.11.020, 21257294.
9. Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second generation versus first generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 2009, 373:31-41. 10.1016/S0140-6736(08)61764-X, 19058842.
10. Leucht S, Pitschel-Walz G, Abraham D, Kissing W. Efficacy and extrapyramidal side-effects of the new antipsychotics olanzapine, quetiapine, risperidone, and sertindole compared to antipsychotics and placebo. A meta-analysis of randomized controlled trials. Schizophr Res 1999, 35:51-68. 10.1016/S0920-9964(98)00105-4, 9988841.
11. Bagnall AM, Jones L, Ginnelly L, Lewis R, Glanville J, Gilbody S, Davies L, Torgerson D, Kleijnen J. A systematic review of atypical antipsychotic drugs in schizophrenia. Health Technol Assess 2003, 7:1-193.
12. Miller CH, Mohr F, Umbricht D, Woerner M, Fleischhacker WW, Lieberman JA. The prevalence of acute extrapyramidal signs and symptoms in patients treated with clozapine, risperidone, and conventional antipsychotics. J Clin Psychiatry 1998, 59:69-75. 10.4088/JCP.v59n0205, 9680055.
13. Rummel-Kluge C, Komossa K, Schwarz S, Hunger H, Schmid F, Kissling W, Davis JM, Leucht S. Second-generation antipsychotic drugs and extrapyramidal side effects: a systematic review and meta-analysis of head-to-head comparisons. Schizophr Bull 2010,
14. RISPERDAL® CONSTA® (risperidone long-acting injection) [package insert] 2008, Titusville, NJ: Janssen LP, RISPERDAL® CONSTA® (risperidone long-acting injection) [package insert].
15. Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, Pretorius H, David AS. Comparative efficacy and safety of long-acting risperidone microspheres and risperidone oral tablets. Eur Neuropsychopharmacol 2005, 15(1):111-117. 10.1016/j.euroneuro.2004.07.003, 15572280.
16. Fleischhacker WW, Eerdekens M, Karcher K, Remington G, Llorca PM, Chrzanowski W, Martin S, Gefvert O. Treatment of schizophrenia with long-acting injectable risperidone: a 12-month open-label trial of the first long-acting second-generation antipsychotic. J Clin Psychiatry 2003, 64(10):1250-1257. 10.4088/JCP.v64n1017, 14658976.
17. Simpson GM, Mahmoud RA, Lasser RA, Kujawa M, Bossie CA, Turkoz I, Rodriguez S, Gharabawi GM. A 1-year double-blind study of 2 doses of long acting risperidone in stable patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry 2006, 67:1194-1203. 10.4088/JCP.v67n0804, 16965196.
18. Chue P, Devos E, Duchesne I, Leal A, Rosillon D, Mehnert A, et al. Hospitalization rates in patients during long-term treatment with long-acting risperidone injection. J Appl Res 2005, 5(2):266-274.
19. Leal A, Rosillon D, Mehnert A, Jarema M, Remington G. Healthcare resource utilization during 1-year treatment with long-acting injectable risperidone. Pharmacoepidemiol Drug Saf 2004, 11:811-816.
20. Keith S. Use of long-acting risperidone in psychiatric disorders: focus on efficacy, safety and cost-effectiveness. Expert Rev Neurother 2009, 9:9-31. 10.1586/14737175.9.1.9, 19102665.
21. Kane JM, Eerdekens M, Lindenmayer JP, Keith SJ, Lesem M, Karcher K. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am J Psychiatry 2003, 160(6):1125-1132. 10.1176/appi.ajp.160.6.1125, 12777271.
22. Ehret MJ, Fuller MA. Long-acting injectable risperidone. Ann Pharmacother 2004, 38(12):2122-2127. 10.1345/aph.1E085, 15522979.
23. Olivares JM, Rodriguez-Morales A, Diels J, Povey M, Jacobs A, Zhao Z, Lam A, Villalobos Vega JC, Cuéllar JA, de Castro FJ, Quintero CM, Martíin JF, Domínguez PT, Ojeda JL, Cortés SS, Cala FI, Marín CG, Castro LM, Duaso MA, Albarracín JR, Vergara GN, Benítez AF, Cleries FM, Pérez-Brian JM, Aragón AB, Navarro JC, Biedma JA, de Pedro RB, González JF, López ME, et al. e-STAR Spanish Study Group Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR). Eur Psychiatry 2009, 24(5):287-296. 10.1016/j.eurpsy.2008.12.002, 19195847, e-STAR Spanish Study Group.
24. Nasrallah HA, Duchesne I, Mehnert A, Janagap C, Eerdekens M. Health-related quality of life in patients with schizophrenia during treatment with long-acting, injectable risperidone. J Clin Psychiatry 2004, 65:531-536. 10.4088/JCP.v65n0412, 15119916.
25. Weiden P, Zygmunt A. Medication noncompliance in schizophrenia. Part I. Assessment. J Pract Psychiatry Behav 1997, 3:106-110.
26. Kane JM. Treatment adherence and long term outcomes. CNS Spectr 2007, 12(10 Suppl 17):21-26.
27. Law MR, Sourerai SB, Ross-Degnan D, Adams AS. A longitudinal study of medication nonadherence and hospitalization risk in schizophrenia. J Clin Psychiatry 2008, 69:47-53. 10.4088/JCP.v69n0107, 18312037.
28. Kissling W. Ideal and reality of neuroleptic relapse prevention. Br J Psychiatry Suppl 1992, 18:133-139.
29. Burton SC. Strategies for improving adherence to second-generation antipsychotics in patients with schizophrenia by increasing ease of use. J Psychiatr Pract 2005, 11:369-378. 10.1097/00131746-200511000-00003, 16304505.
30. Guy W. Clinical global impressions. ECDEU Assessment Manual of Psychopharmacology 1976, 217-222. Revised 1976. US Department of Health, Education, and Welfare; Rockville, MD.
31. Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand 2000, 101:323-329.
32. American Psychiatric Association Handbook of Psychiatric Measures 2000, Washington, DC: APA, American Psychiatric Association.
33. Strauss JS, Carpenter WTJ. Prediction of outcome in schizophrenia: III. Five-year outcome and its predictors. Arch Gen Psychiatry 1977, 34:159-163.
34. Ware JE, Sherbourne CD. The MOS 36-item short form health survey (SF-36): conceptual framework and item selection. Med Care 1992, 30:473-483. 10.1097/00005650-199206000-00002, 1593914.
35. Linden M, Godemann F, Gaebel W, Köpke W, Müller P, Müller-Spahn F, Pietzcker A, Tegeler J. A prospective study of factors influencing adherence to a continuous neuroleptic treatment program in schizophrenia patients during 2 years. Schizophr Bull 2001, 27:585-596.
36. Buchanan A. A two-year prospective study of treatment compliance in patients with schizophrenia. Psychol Med 1992, 22:787-797. 10.1017/S0033291700038228, 1357703.
37. Möller HJ, Llorca PM, Sacchetti E, Martin SD, Medori R, Parellada E, . StoRMi Study Group Efficacy and safety of direct transition to risperidone long-acting injectable in patients treated with various antipsychotic therapies. Int Clin Psychopharmacol 2005, 20:121-130. 10.1097/00004850-200505000-00001, 15812261, StoRMi Study Group.
38. Kim B, Lee S-H, Choi TK, Kim Y-W, Lee E-H, Yook K-H. Effectiveness of risperidone long-acting injection in first-episode schizophrenia: in naturalistic setting. Prog Neuro-Psychopharm Biol Psychiatry 2008, 32:1231-1235.
39. Gastpar M, Masiak M, Latif MA, Frazzingaro S, Medori R, Lombertie E-R. Sustained improvement of clinical outcome with risperidone long-acting injectable in psychotic patients previously treated with olanzapine. J Psychopharmacol 2005, 19(5Suppl):32-38.
40. Parellada E, Andrezina R, Milanova V, Glue P, Masiak M, Turner MS, Medori R, Gaebel W. Patients in the early phases of schizophrenia and schizoaffective disorders effectively treated with risperidone long-acting injectable. J Psychopharmacol 2005, 19(5 Suppl):5-14. 10.1177/0269881105056513, 16144781.
41. DeMarinis T, Saleem PT, Glue P, Arnoldussen WJ, Teijeiro R, Lex A, Latif MA, Medori R. Switching to long-acting injectable risperidone is beneficial with regard to clinical outcomes, regardless of previous conventional medication in patients with schizophrenia. Pharmacopsychiatry 2007, 40(6):257-263. 10.1055/s-2007-992140, 18030649.
42. Curtis VA, Katsafouros K, Möller HJ, Medori R, Sacchetti E. Long-acting risperidone improves negative symptoms in stable psychotic patients. J Psychopharmacol 2008, 22(3):254-261. 10.1177/0269881107082119, 18308804.
43. Peuskens J, Olivares JM, Pecenak J, Tuma I, Bij de Weg H, Eriksson L, Resseler S, Akhras K, Jacobs A. Treatment retention with risperidone long-acting injection: 24 month results from the Electronic Schizophrenia Treatment Adherence Registry (eSTAR) in six countries. Curr Med Res Opin 2010, 26(3):501-509. 10.1185/03007990903488670, 20014981.
44. Olivares JM, Peuskens J, Pecenak J, Resseler S, Jacobs A, Akhras KS, . e-STAR Study Group Clinical and resource-use outcomes of risperidone long-acting injection in recent and long-term diagnosed schizophrenia patients: results from a multinational electronic registry. Curr Med Res Opin 2009, 25(9):2197-2206. 10.1185/03007990903149306, 19604073, e-STAR Study Group.
45. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000, 342(25):1878-1886. 10.1056/NEJM200006223422506, 10861324.