Subject selection for the placebo- and comparator-controlled trials of neuroleptics in schizophrenia

Journal of Clinical Psychopharmacology

Volumn 20, Issue 2, 2000, Pages 240-245

  Mohr, Pavel ^a,b   Czobor, Pál ^a,c  

^a NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

^b NATIONAL INSTITUTE OF MENTAL HEALTH   (Czech Republic)

^c NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLOZAPINE; HALOPERIDOL; NEUROLEPTIC AGENT; OLANZAPINE; PERPHENAZINE; PLACEBO; QUETIAPINE; RISPERIDONE; SERTINDOLE; ZUCLOPENTHIXOL;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; FEMALE; GENDER; HUMAN; HYPOTHESIS; MALE; MEDICAL RESEARCH; META ANALYSIS; PATIENT SELECTION; PRIORITY JOURNAL; PSYCHOPHARMACOLOGY; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA;

ANTIPSYCHOTIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SCHIZOPHRENIA; SELECTION BIAS; SEX FACTORS;

EID: 0034119094     PISSN: 02710749     EISSN: None     Source Type: Journal    
DOI: 10.1097/00004714-200004000-00018     Document Type: Article

References (44)

1. Forrest AD. Assessment of drugs in schizophrenia: diagnosis and patient selection. Br J Clin Pharmacol 1976;3[suppl 2]:367-70.
2. Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials 1997;18:328-52.
3. Spohn HG, Fitzpatrick T. Informed consent and bias in samples of schizophrenic subjects at risk for drug withdrawal. J Abnorm Psychol 1980;89:79-92.
4. Schubert DSP, Patterson MB, Miller FT, Brocco KJ. Informed consent as a source of bias in clinical research. Psychol Res 1984;12:313-20.
5. Robinson D, Woerner MG, Pollack S, Lerner G. Subject selection biases in clinical trials: data from a multicenter schizophrenia treatment study. J Clin Psychopharmacol 1996;16:170-6.
6. Hofer A, Walch T, Hummer M, Kurz M, Fleischhacker WW. Selection bias in clinical trials with antipsychotics [abstract]. Eur Neuropsychopharmacol 1997;7[suppl 2]:S204.
7. Hambrecht M, Maurer K, Häfner H. Evidence for a gender bias in epidemiological studies of schizophrenia. Schizophr Res 1992; 8:223-31.
8. Guelfi JD, Boyer P, Dreyfus JF. Placebo use in clinical trials on psychotropic drugs in France. Neuropsychobiology 1983;9:20-5.
9. Henn FA, Lader M, Helmchen H. Medication-free research with schizophrenic patients: a European perspective. Arch Gen Psychiatry 1997;54:412-3.
10. Rothman KJ, Michel KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331:394-8.
11. Addington D. The use of placebos in clinical trials for acute schizophrenia. Can J Psychiatry 1995;40:171-6.
12. Carpenter WT Jr, Schooler NR, Kane JM. The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 1997;54:401-7.
13. Guy W, ed. ECDEU assessment manual for psychopharmacology, revised. Rockville, MD: U.S. Department of Health, Education, and Welfare, 1976, Publication ADM76-338.
14. Arvanitis LA, Miller BG, The Seroquel Trial 13 Study Group. Multiple fixed doses of "Seroquel" (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. Biol Psychiatry 1997;42:233-46.
15. Beasley CM Jr, Tollefson G, Tran P, Satterlee W, Sanger T, Hamilton S, Olanzapine HGAD Study Group. Olanzapine versus placebo and haloperidol: acute phase results of the North American double-blind olanzapine trial. Neuropsychopharmacol 1996;14:11-23.
16. Beasley CM Jr, Sanger T, Satterlee W, Tollefson G, Tran P, Hamilton S, Olanzapine HGAP Study Group. Olanzapine versus placebo: results of a double-blind, fixed-dose olanzapine trial. Psychopharmacology (Berl) 1996;124:159-67.
17. Borison RL, Pathiraja AP, Diamond BI, Meibach RC. Risperidone: clinical safety and efficacy in schizophrenia. Psychopharmacol Bull 1992;28:213-8.
18. Borison RL, Arvanitis LA, Miller BG, The US Seroquel Study Group. ICI 204,636, an atypical antipsychotic: efficacy and safety in a multicenter, placebo-controlled trial in patients with schizophrenia. J Clin Psychopharmacol 1996;16:158-69.
19. Chouinard G, Jones B, Remington G, Bloom D, Addington D, MacEwan GW, Labelle A, Beauclair L, Arnott W. A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients. J Clin Psychopharmacol 1993;13:25-40.
20. Fabre LF, Arvanitis L, Pultz J, Jones VM, Malick JB, Slotnick VB. ICI 204,636, a novel, atypical antipsychotic: early indication of safety and efficacy in patients with chronic and subchromc schizophrenia. Clin Ther 1995;17:366-78.
21. Marder RS, Meibach RC. Risperidone in the treatment of schizophrenia. Am J Psychiatry 1994;151:825-35.
22. McEvoy J, Borison R, Small J, van Kammen D, Meltzer H, Hamner M, Morris D, Shu V, Sebree T, Grebb J. The efficacy and tolerability of sertindole in schizophrenic patients: a pilot, double-blind, placebo-controlled, dose-ranging study [abstract]. Schizophr Res 1993;9:244.
23. Small JG, Hirsch SR, Arvanitis LA, Miller BG, Link CGG, The Seroquel Study Group. Quetiapine in patients with schizophrenia. Arch Gen Psychiatry 1997;54:549-57.
24. van Kammen DP, McEvoy JP, Targum SD, Kardatzke D, Sebree TB, The Sertindole Study Group. A randomized, controlled, dose-ranging trial of sertindole in patients with schizophrenia. Psychopharmacology (Berl) 1996;124:168-75.
25. Zimbroff DL, Kane JM, Tamminga CA, Daniel DG, Mack RJ, Wozniak PJ, Sebree TB, Wallin BA, Kashkin KB, The Sertindole Study Group. Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Am J Psychiatry 1997;154:782-91.
26. Beasley CM Jr, Hamilton SH, Crawford AM, Dellva MA, Tollefson GD, Tran PV, Blin O, Beuzen JN. Olanzapine versus haloperidol: acute phase results of the international double-blind olanzapine trial. Eur Neuropsychopharmacol 1997;7:125-37.
27. Blin O, Azorin JM, Bouhours P. Antipsychotic and anxiolytic properties of risperidone, haloperidol, and methotrimeprazine in schizophrenic patients. J Clin Psychopharmacol 1996;16:38-44.
28. Bondolfi G, Dufour H, Patris M, May JP, Billeter U, Eap CB, Baumann P, The Risperidone Study Group. Risperidone versus clozapine in treatment-resistant schizophrenia: a randomized double-blind study. Am J Psychiatry 1998;155:499-504.
29. Češková E, Švestka J. Double-blind comparison of risperidone and haloperidol in schizophrenic and schizoaffective psychoses. Pharmacopsychiatry 1993;26:121-4.
30. Claus A, Bollen J, DeCuyper H, Eneman M, Malfroid M, Peuskens J, Heylen S. Risperidone versus haloperidol in the treatment of chronic schizophrenic inpatients: a multicentre double-blind comparative study. Acta Psychiatr Scand 1992;85:295-305.
31. Hoyberg OJ, Fensbo C, Remvig J, Lingjaerde O, Sloth-Nielsen M, Salvesen I. Risperidone versus perphenazine in the treatment of chronic schizophrenic patients with acute exacerbations. Acta Psychiatr Scand 1993;88:395-402.
32. Huttunen MO, Piepponen T, Rantanen H, Larmo I, Nyholm R, Raitasuo V. Risperidone versus zuclopenthixol in the treatment of acute schizophrenic episodes: a double-blind parallel-group trial. Acta Psychiatr Scand 1995;91:271-7.
33. Klieser E, Strauss WH, Lemmer W. The tolerability and efficacy of the atypical neuroleptic remoxipride compared with clozapine and haloperidol in acute schizophrenia. Acta Psychiatr Scand 1994;8[suppl 380]:68-73.
34. Min SK, Rhee CS, Kim CE, Kang DY. Risperidone versus haloperidol in the treatment of chronic schizophrenic patients: a parallel group double-blind comparative trial. Yonsei Med J 1993;34: 179-90.
35. Peuskens J, The Risperidone Study Group. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Br J Psychiatry 1995;166:712-26.
36. Tollefson GD, Beasley CM Jr, Tran PV, Street JS, Kruefger JA, Tamura RN, Graffeo KA, Thieme ME. Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial. Am J Psychiatry 1997;154:457-65.
37. Tran PV, Hamilton SH, Kuntz AJ, Potvin JH, Andersen SW, Beasley C Jr, Tollefson GD. Double-blind comparison of olanzapine versus risperidone in the treatment of schizophrenia and other psychotic disorders. J Clin Psychopharmacol 1997;17: 407-18.
38. Meltzer HY, Rabinowitz J, Lee MA, Cola PA, Ranjan R, Findling RL, Thompson PA. Age at onset and gender of schizophrenic patients in relation to neuroleptic resistance. Am J Psychiatry 1997;154:475-82.
39. Loebel AD, Lieberman JA, Alvir JM, Mayerhoff DI, Geisler SH, Szymanski SR. Duration of psychosis and outcome in first-episode schizophrenia. Am J Psychiatry 1992;149:1183-8.
40. Jeste DV, Eastham JH, Lacro JP, Gierz M, Field MG, Harris MJ. Management of late-life psychosis. J Clin Psychiatry 1996;57 [suppl 3]:39-45.
41. Findling RL, Grcevich SJ, Lopez I, Schulz SC. Antipsychotic medications in children and adolescents. J Clin Psychiatry 1996;57 [suppl 9]:19-23.
42. Hambrecht M, Riecher-Rossler A, Fatkenheuer B, Louza MR, Hafner H. Higher morbidity risk for schizophrenia in males: fact or fiction? Compr Psychiatry 1994;35:39-49.
43. Tamminga CA. Gender and schizophrenia. J Clin Psychiatry 1997; 58[suppl 15]:33-7.
44. Lieberman JA, Koreen AR, Chakos M, Sheitman B, Woerner M, Alvir JM, Bilder R. Factors influencing treatment response and outcome of first-episode schizophrenia implications for understanding the pathophysiology of schizophrenia. J Clin Psychiatry 1996;57[suppl 9]:5-9.