A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia

Journal of Clinical Psychiatry

Volumn 72, Issue 2, 2011, Pages 194-204

  Kane, John M ^a,b   Potkin, Steven G ^c   Daniel, David G ^d,e   Buckley, Peter F ^f  

^a ZUCKER HILLSIDE HOSPITAL   (United States)

^b ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^e Bioniche Development   (United States)

^f MEDICAL COLLEGE OF GEORGIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HALOPERIDOL; RISPERIDONE; SERTINDOLE;

ACCIDENTAL INJURY; ADULT; AKATHISIA; ARTICLE; BRIEF PSYCHIATRIC RATING SCALE; CLINICAL GLOBAL IMPRESSION SCALE; DEPRESSION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPEPSIA; EJACULATION; EXTRAPYRAMIDAL SYNDROME; FEMALE; HEADACHE; HUMAN; HYPERSALIVATION; INFECTION; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEGATIVE SYNDROME; PAIN; PHASE 3 CLINICAL TRIAL; POSITIVE AND NEGATIVE SYNDROME SCALE; POSITIVE SYNDROME; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SCHIZOPHRENIA; SIDE EFFECT; SOMNOLENCE; SUICIDE ATTEMPT; VOMITING;

ADULT; ANTIPSYCHOTIC AGENTS; DOUBLE-BLIND METHOD; DRUG RESISTANCE; DRUG TOXICITY; DYSKINESIA, DRUG-INDUCED; FEMALE; HALOPERIDOL; HUMANS; IMIDAZOLES; INDOLES; MALE; MIDDLE AGED; PSYCHIATRIC STATUS RATING SCALES; RISPERIDONE; SCHIZOPHRENIA; SCHIZOPHRENIC PSYCHOLOGY; TREATMENT OUTCOME;

EID: 79952000508     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.07m03733yel     Document Type: Article

References (60)

1. Buckley PF, Shendarkar N. Treatment-refractory schizophrenia. Curr Opin Psychiatry. 2005;18(2):165-173. doi:10.1097/01504-205030-010 PubMed (Pubitemid 40824449)
2. Robinson DG, Woerner MG, Alvir JM, et al. Predictors of treatment response from a first episode of schizophrenia or schizoaffective disorder. Am J Psychiatry. 1999;156(4):544-549.
3. Bunney BS. Antipsychotic drug effects on the electrical activity of dopaminergic neurones. Trends Neurosci. 1984;7(6):212-215. doi:10.1016/S016- 236(84)8013-2 (Pubitemid 14122421)
4. Fleischhacker WW. New drugs for the treatment of schizophrenic patients. Acta Psychiatrica Scandinavica. 1995;92(suppl 388):24-30.
5. Hale AS. Atypical antipsychotic and compliance in schizophrenia. Nord Psykiatr Tidsskr. 1995;49(s35):31-39.
6. Kane J, Honigfeld G, Singer J, et al. Clozapine for the treatment-resistant schizophrenic: a double-blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988;45(9):789-796.
7. Wahlbeck K, Cheine M, Essali A, et al. Evidence of clozapine's effectiveness in schizophrenia: a systematic review and meta-analysis of randomized trials. Am J Psychiatry. 1999;156(7):990-999.
8. Volavka J, Czobor P, Sheitman B, et al. Clozapine, olanzapine, risperidone, and haloperidol in the treatment of patients with chronic schizophrenia and schizoaffective disorder. Am J Psychiatry. 2002; 159(2):255-262. doi:10.176/api.ajp.159.2.25 PubMed (Pubitemid 34126903)
9. Chakos M, Lieberman J, Hoffman E, et al. Effectiveness of second-generation antipsychotics in patients with treatment-resistant schizophrenia: a review and meta-analysis of randomized trials. Am J Psychiatry. 2001;158(4):518-526. doi:10.176/api.ajp.158.4.518 PubMed (Pubitemid 32289814)
10. Breier A, Hamilton SH. Comparative efficacy of olanzapine and haloperidol for patients with treatment-resistant schizophrenia. Biol Psychiatry. 1999;45(4):403-411. doi:10.1016/S06-323(98)0291-1 PubMed (Pubitemid 29130436)
11. Conley RR, Tamminga CA, Bartko JJ, et al. Olanzapine compared with chlorpromazine in treatment-resistant schizophrenia. Am J Psychiatry. 1998;155(7):914-920.
12. Dinakar HS, Sobel RN, Bopp JH, et al. Efficacy of olanzapine and risperidone for treatment-refractory schizophrenia among long-stay state hospital patients. Psychiatr Serv. 2002;53(6):755-757. doi:10.176/api.ps.53.6.75 (Pubitemid 34568608)
13. Bondolfi G, Dufour H, Patris M, et al; The Risperidone Study Group. Risperidone versus clozapine in treatment-resistant chronic schizophrenia: a randomized double-blind study. Am J Psychiatry. 1998;155(4):499-504.
14. Breier AF, Malhotra AK, Su TP, et al. Clozapine and risperidone in chronic schizophrenia: effects on symptoms, parkinsonian side effects, and neuroendocrine response. Am J Psychiatry. 1999;156(2):294-298.
15. Lindenmayer JP, Iskander A, Park M, et al. Clinical and neurocognitive effects of clozapine and risperidone in treatment-refractory schizophrenic patients: a prospective study. J Clin Psychiatry. 1998;59(10):521-527.
16. Sharif ZA, Raza A, Ratakonda SS. Comparative efficacy of risperidone and clozapine in the treatment of patients with refractory schizophrenia or schizoaffective disorder: a retrospective analysis. J Clin Psychiatry. 2000;61(7):498-504.
17. Buckley PF, Goldstein JM, Emsley RA. Efficacy and tolerability of quetiapine in poorly responsive, chronic schizophrenia. Schizophr Res. 2004; 66(2-3):143-150. doi:10.1016/j.schres.203.06.01 PubMed (Pubitemid 38041112)
18. Wirshing DA, Wirshing WC, Kysar L, et al. Novel antipsychotics: comparison of weight gain liabilities. J Clin Psychiatry. 1999;60(6):358-363.
19. Hale AS. A review of the safety and tolerability of sertindole. Int Clin Psychopharmacol. 1998;13(suppl 3):S65-S70. doi:10.1097/04850-1980303-01 PubMed (Pubitemid 28282873)
20. Azorin J-M, Strub N, Loft H. A double-blind, controlled study of sertindole versus risperidone in the treatment of moderate-to-severe schizophrenia. Int Clin Psychopharmacol. 2006;21(1):49-56. doi:10.1097/01.yic. 017020.2631.a7 PubMed (Pubitemid 43175123)
21. Tamminga CA, Mack RJ, Granneman GR, et al. Sertindole in the treatment of psychosis in schizophrenia: efficacy and safety. Int Clin Psychopharmacol. 1997;12(suppl 1):S29-S35. doi:10.1097/04850-1970201-05 PubMed (Pubitemid 27171186)
22. Weiden PJ, Mackell JA, McDonnell DD. Obesity as a risk factor for antipsychotic noncompliance. Schizophr Res. 2004;66(1):51-57. doi:10.1016/S0920-964(02)0498-X PubMed (Pubitemid 38030344)
23. Hale A, Azorin J-M, Kasper S, et al. Sertindole improves both the positive and negative symptoms of schizophrenia: results of a phase III trial. Int J Psych Clin Prac. 2000;4(1):55-62. doi:10.1080/136515050518406 (Pubitemid 30198337)
24. Kane JM. Sertindole: a review of clinical efficacy. Int Clin Psychopharmacol. 1998;13(suppl 3):S59-S63, discussion S63-S64.
25. Zimbroff DL, Kane JM, Tamminga CA, et al; Sertindole Study Group. Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Am J Psychiatry. 1997;154(6):782-791.
26. 2 and alpha 1 receptors (ex vivo radioreceptor binding studies). J Neural Transm Gen Sect. 1992;89(1-2):61-69.
27. Sánchez C, Arnt J, Dragsted N, et al. Neurochemical and in vivo pharmacological profile of sertindole, a limbic-selective neuroleptic compound. Drug Dev Res. 1990;22(3):239-250.
28. Arnt J. Differential effects of classical and newer antipsychotics on the hypermotility induced by two dose levels of D-amphetamine. Eur J Pharmacol. 1995;283(1-3):55-62.
29. 1)-adrenoceptor antagonism. Eur Neuropsychopharmacol. 2000;10(4):245-253.
30. Skarsfeldt T. Electrophysiological profile of the new atypical neuroleptic, sertindole, on midbrain dopamine neurones in rats: acute and repeated treatment. Synapse. 1992;10(1):25-33.
31. van Kammen DP, McEvoy JP, Targum SD, et al. A randomized, controlled, dose-ranging trial of sertindole in patients with schizophrenia. Psychopharmacology (Berl). 1996;124(1-2):168-175. doi:10.107/BF0245618 PubMed (Pubitemid 26112786)
32. Daniel DG, Wozniak P, Mack RJ, et al; The Sertindole Study Group. Long-term efficacy and safety comparison of sertindole and haloperidol in the treatment of schizophrenia. Psychopharmacol Bull. 1998;34(1): 61-69.
33. Moore N. Higher cardiovascular mortality with sertindole in ADROIT: a signal not confirmed. Int J Psychiatry Clin Pract. 2002;6(1):3-9.
34. Leysen JE, Gommeren W, Eens A, et al. Biochemical profile of risperidone, a new antipsychotic. J Pharmacol Exp Ther. 1988;247(2):661-670.
35. Arnt J, Skarsfeldt T. Do novel antipsychotics have similar pharmacological characteristics? a review of the evidence. Neuropsychopharmacology. 1998;18(2):63-101. doi:10.1016/S0893-13X(97)012-7 PubMed (Pubitemid 28026679)
36. Geddes J, Freemantle N, Harrison P, et al. Atypical antipsychotics in the treatment of schizophrenia: systematic overview and meta-regression analysis. BMJ. 2000;321(7273):1371-1376.
37. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000.
38. Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-276.
39. Overall JE, Gorham DR. The Brief Psychiatric Rating Scale. Psychol Rep. 1962;10(3):799-812.
40. Guy W. ECDEU Assessment Manual for Psychopharmacology. US Dept of Health and Human Services publication (ADM) 76-338. Rockville, MD: National Institute of Mental Health; 1976; 534-537.
41. Simpson GM, Angus JWS. A rating scale for extrapyramidal side effects. Acta Psychiatrica Scandinavica. 1970;45(S212):11-19.
42. Barnes TR. A rating scale for drug-induced akathisia. Br J Psychiatry. 1989;154:672-676. (Pubitemid 19154942)
43. Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982;39(7):784-788.
44. Guy W. ECDEU Assessment Manual for Psychopharmacology. US Dept Health, Education, and Welfare publication (ADM) 76-338. National Institute of Mental Health; 1976; 218-222.
45. Department of Health and Human Services. Coding Symbols for Thesaurus of Adverse Reaction Terms. 3rd ed. Rockville, MD: Food and Drug Administration; 1989.
46. Wirshing WC, Ames D, Marder SR, et al. Risperidone in treatment resistant schizophrenia. 34th Annual Meeting of the American College of Neuropsychopharmacology; Dec 11-15, 1995; San Juan, Puerto Rico, 1995, Abstract 270.
47. Moore N, Hall G, Sturkenboom M, et al. Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf. 2003;12(4):271-281. doi:10.102/pds.848 PubMed (Pubitemid 36700601)
48. Peuskens J, Moore N, Azorin J-M, et al. Sertindole European Safety and Exposure Survey: a retrospective study of 8,608 patients in Europe. Poster presented at International Consortium in Psychiatric Epidemiology; August 2002; Edinburgh, Scotland.
49. Lindström E, Farde L, Eberhard J, et al. QTc interval prolongation and antipsychotic drug treatments: focus on sertindole. Int J Neuropsychopharmacol. 2005;8(4):615-629. doi:10.1017/S14614570505250 PubMed (Pubitemid 41400893)
50. Moore N, Peuskens J, Man R, et al. Outcome of the Sertindole Cohort Prospective (SCoP) Study: All-cause Mortality. Poster at the XIV World Congress of Psychiatry (WPA); September 2008; Prague, Czech Republic.
51. Lean ME, Pajonk FG. Patients on atypical antipsychotic drugs: another high-risk group for type 2 diabetes. Diabetes Care. 2003;26(5): 1597-1605. doi:10.237/diacare.26.5.1597 PubMed (Pubitemid 36929197)
52. Allison DB, Mentore JL, Heo M, et al. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999;156(11): 1686-1696.
53. Nasrallah H. A review of the effect of atypical antipsychotics on weight. Psychoneuroendocrinology. 2003;28(suppl 1):83-96. doi:10.1016/S0306-4530(02) 014-2 PubMed (Pubitemid 36015663)
54. Hale A, Azorin JM, Kasper S, et al. Sertindole is associated with a low level of extrapyramidal symptoms in schizophrenic patients: results of a phase III trial. Int J Psychiatry Clin Pract. 2000;4(1):47-54. doi:10.1080/ 136515052048758 (Pubitemid 30198336)
55. Alberti KG, Zimmet P, Shaw J. Metabolic syndrome - a new world-wide definition: a Consensus Statement from the International Diabetes Federation. Diabet Med. 2006;23(5):469-480.
56. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001;285(19):2486-2497.
57. McEvoy JP, Lieberman JA, Stroup TS, et al; CATIE Investigators. 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(4):600-610. doi:10.176/api.ajp.163.4.60 PubMed (Pubitemid 44464569)
58. Stroup TS, Lieberman JA, McEvoy JP, et al; CATIE Investigators. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006;163(4):611-622. doi:10.176/api.ajp.163.4.61 PubMed (Pubitemid 44464570)
59. Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of secondgeneration antipsychotics. Arch Gen Psychiatry. 2003;60(6):553-564.
60. Csernansky JG, Mahmoud R, Brenner R; Risperidone-USA-79 Study Group. A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. N Engl J Med. 2002;346(1):16-22. doi: 10.1056/NEJMoa02028 PubMed (Pubitemid 34438915)