A review of the efficacy, tolerability and safety of sertindole in clinical trials

CNS Drugs

Volumn 18, Issue SUPPL. 2, 2004, Pages 19-30

  Perquin, Lowijs ^a   Steinert, Tilman ^b  

^a Valeriuskliniek   (Netherlands)

^b Weissenau Research Unit   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ATYPICAL ANTIPSYCHOTIC AGENT; CHLORPROMAZINE; CLOZAPINE; HALOPERIDOL; NEUROLEPTIC AGENT; OLANZAPINE; QUETIAPINE; RISPERIDONE; SERTINDOLE; THIORIDAZINE; ZIPRASIDONE;

AKATHISIA; ASTHENIA; BODY WEIGHT DISORDER; CLINICAL TRIAL; COGNITION; CONFERENCE PAPER; CONSTIPATION; DEPRESSION; DIZZINESS; DOSE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; DYSTONIA; EJACULATION DISORDER; EXTRAPYRAMIDAL SYNDROME; HEADACHE; HEART ARRHYTHMIA; HUMAN; INFECTION; INSOMNIA; MORTALITY; MOTOR DYSFUNCTION; MUSCLE HYPERTONIA; MYALGIA; NAUSEA; NEGATIVE SYNDROME; PARKINSONISM; POSITIVE SYNDROME; PRIORITY JOURNAL; RHINITIS; SCHIZOPHRENIA; SOMNOLENCE; SUICIDE; TARDIVE DYSKINESIA; TASK PERFORMANCE; TORSADE DES POINTES; TREMOR; XEROSTOMIA;

ANTIPSYCHOTIC AGENTS; BASAL GANGLIA DISEASES; CARDIOVASCULAR DISEASES; CLINICAL TRIALS; COGNITION; DRUG TOLERANCE; DYSKINESIA, DRUG-INDUCED; HUMANS; IMIDAZOLES; INDOLES; NEUROPSYCHOLOGICAL TESTS; PSYCHIATRIC STATUS RATING SCALES; SCHIZOPHRENIA; SCHIZOPHRENIC PSYCHOLOGY; SUICIDE; TREATMENT OUTCOME;

EID: 3042701604     PISSN: 11727047     EISSN: None     Source Type: Journal    
DOI: 10.2165/00023210-200418002-00003     Document Type: Conference Paper

References (28)

1. Sanchez C, Arnt J, Dragsted N. Neurochemical and in vivo pharmacological profile of sertindole, a limbic-selective neuroleptic compound. Drug Dev Res 1992; 22:239-50
2. 2 and alpha one receptors. J Neural Transm 1992; 89:61-9
3. Skarsfeldt T. Electrophysiological profile of the new atypical neuroleptic, sertindole, on midbrain dopamine neurones in rats: acute and repeated treatment. Synapse 1992; 10:25-33
4. van Kammen DP, McEvoy JP, Targum SD, et al. A randomized, controlled, dose-ranging trial of sertindole in patients with schizophrenia. Psychopharmacology (Berl) 1996; 124:168-75
5. Kasper S. How much do novel antipsychotics benefit the patients? Int Clin Psychopharmacol 1998; 13 (Suppl. 3):S71-S7
6. Zimbroff DL, Kane JM, Tamminga CA, et al. Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Am J Psychiatry 1997; 154:782-91
7. 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 Psychiatry Clin Pract 2000; 4:55-62
8. Daniel DG, Wozniak PJ, Mack RJ, et al. Long-term efficacy and safety comparison of sertindole and haloperidol in the treatment of schizophrenia. Psychopharmacol Bull 1998; 34:61-9
9. Haverkamp W, Eckhardt L, Matz J, et al. Sertindole: cardiac electrophysiological profile. Int J Psychiatry Clin Pract 2002; 6 (Suppl. 1):S11-S20
10. Moore N. Higher cardiovascular mortality with sertindole in ADROIT: a signal not confirmed. Int J Psychiatry Clin Pract 2002; 6 (Suppl. 1):S3-S9
11. Branford D, Thompson B, Muldoon C. Mortality in three comparative cohorts of patients who received sertindole, risperidone, and olanzapine: a hospital-based retrospective study. Poster presented at ICPE. Edinburgh, 18-21 August 2002
12. Wilton LV, EL H, Pickering RM, et al. Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine. J Psychopharmacol (Oxf) 2001; 15):120-6
13. Azorin J-M, Toumi M, Sloth-Nielsen M. Sertindole is well tolerated and demonstrates efficacy advantages over risperidone in the treatment of moderate to severe schizophrenia. Poster presented at ECNP. Barcelona, 5-9 October 2002
14. Hale A. Sertindole: a clinical efficacy profile. Psychiatry Clin Pract 2002; 6 (Suppl. 1):S21-S6
15. Lis S, Krieger S, Gallhofer B, et al. Sertindole is superior to haloperidol in cognitive performance in patients with schizophrenia: a comparative study. Poster presented at ECNP. Prague, 20-24 September 2003
16. Steinert T, Hauger B, Eckhardt J, et al. Clinical observations of sertindole in 53 consecutive cases. Psycopharmakotherapie 2003; 10:62-5
17. Hale AS. A review of the safety and tolerability of sertindole. Int Clin Psychopharmacol 1998; 13 (Suppl. 3):S65-S70
18. Lundbeck. data on file
19. Serdolect® (sertindole) monograph. Available at URL http://www.serdolect.com Accessed 13 November 2003
20. Glassman AH, Bigger JT Jr. Antipsychotic drugs: prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry 2001; 158:1774-82
21. 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
22. Eckardt L, Breithardt G, Haverkamp W. Electrophysiologic characterisation of the antipsychotic drug sertindole in a rabbit heart model of torsade de points: low torsadogenic potential despite QT prolongation. J Pharmacol Exp Ther 2002; 300:64-71
23. Toumi M, Anquier P, Francois C. The safety and tolerability of sertindole in a patient name use programme. Poster presented at ICPE. Edinburgh, 18-21 August 2002
24. Peuskens J, Moore N, Azorin J, et al. Sertindole European Safety and Exposure Survey: a retrospective study of 8,608 patients in Europe. Poster presented at ICPE. Edinburgh, 18-21 August 2002
25. Sturkenboom MCJM, Picelli G, Moore N. Mortality during use of sertindole and other anti-psychotics in the Netherlands and Belgium. Pharmacoepidemiol Drug Safety 2001; 10(Suppl. 1):S116
26. Kasper S, Quiner S, Pezawas L. A review of the benefit: risk profile of sertindole. Int J Psychiatry Clin Pract 1998; 2 (Suppl. 2):S59-S64
27. Meltzer HY, Baldessarini RJ. Reducing the risk for suicide in schizophrenia and affective disorders. J Clin Psychiatry 2003; 64:1122-9
28. Meltzer HY, Alphs L, Green AI, et al. Clozapine treatment for suicidality in schizophrenia: International Suicide Prevention Trial (InterSePT). Arch Gen Psychiatry 2003; 60:82-91