Clinical trials of new antipsychotics: A critical appraisal

International Clinical Psychopharmacology

Volumn 14, Issue 2, 1999, Pages 133-137

  Barbui, C ^a   Garattini, S ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

Antipsychotic drugs; Randomized controlled trials; Schizophrenia; Trial methodology

Indexed keywords

CLOZAPINE; HALOPERIDOL; NEUROLEPTIC AGENT; OLANZAPINE; ZOTEPINE;

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG EFFICACY; EXTRAPYRAMIDAL SYMPTOM; HUMAN; METHODOLOGY; NEGATIVE SYNDROME; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SCHIZOPHRENIA; TREATMENT PLANNING;

EID: 0033060259     PISSN: 02681315     EISSN: None     Source Type: Journal    
DOI: 10.1097/00004850-199903000-00012     Document Type: Review

References (27)

1. Altman DJ, Bland JM (1995) Absence of evidence in not evidence of absence. BMJ 311:485.
2. Barbui, C (1998) Olanzapine on trial. Am J Psychiatry 155:152-153.
3. Barnas C, Stuppack CH, Miller C, Haring C, Sperner-Unterweger B, Fleischhacker WW (1992) Zotepine in the treatment ot schizophrenic patients with prevailingly negative symptoms. A double-blind trial versus haloperidol. Int Clin Psychopharmacol 7:23-27.
4. Beasley CM, Hamilton SH, Crawford AM, Dellva MA, Tollefson GD, Tran PV, et al. (1997) Olanzapine versus haloperidol: acute phase results of the international double-blind olanzapine trial. Eur Neuropsychopharmacol 7:125-137.
5. Beasley CM, Tollefson G, Tran P, Satterlee W, Sanger T, Hamilton S, The Olanzapine HGAD Study Group (1996) Olanzapine versus placebo and haloperidol. Acute phase results of the North American double-blind olanzapine trial. Neuropsychopharmacology 14:111-123.
6. Bondolfi G (1996) Treatment resistant schizophrenia: clinical experience with new antipsychotics. Eur Neuropharmacol 6:S2-S21.
7. Bondolfi G, Dufour H, Patris M, May JP, Billeter U, Eap CB, Baumann P (1998) Risperidone versus clozapine in treatment-resistant chronic schizophrenia: a randomized double-blind study. Am J Psychiatry 155:499-504.
8. Cook RJ, Sackett DL (1995) The number needed to treat: a clinically useful measure of treatment effect. BMJ 310:452-454.
9. Cunningham-Owens DG (1996) Adverse effects of antipsychotic agents: do newer agents offer advantages? Drugs 51:895-930.
10. Feinstein AR (1998) The problem of cogent subgroups: a clinicostatistical tragedy. J Clin Epidemiol 51:297-299.
11. Fleischhacker WW, Barnas C, Stuppack CH, Unterweger B, Miller C, Hinterhuber H (1989) Zotepine versus haloperidol in paranoid schizophrenia: a double-blind trial. Psychopharmacol Bull 25:97-100.
12. Geddes J, Harrison PJ (1997) Closing the gap between research and practice. Br J Psychiatry 171:220-225.
13. Greenhalgh, T (1997) Papers that report drug trials. BMJ 315:480-483.
14. Guyatt GH, Sackett DL, Cook DJ (1994) How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? JAMA 271:59-63.
15. Jones B, Jarvis P, Lewis JA, Ebbutt AF (1996) Trials to assess equivalence: the importance of rigorous method. BMJ 313:36-39.
16. Keith SJ (1997) Pharmacologic advances in the treatment of schizophrenia. N Engl J Med 337:851-852.
17. Kervin, R (1997) Olanzapine. Lancet 350:594.
18. Konrad C, Schormair C, Knickelbein, U (1997) Risperidone and clozapine in pharmacoresistant schizophrenia [abstract]. American Psychiatric Association Meeting.
19. Meyer-Lindenberg A, Gruppe H, Bauer U, Lis S, Krieger S, Gallhofer B (1997) Improvement of cognitive function in schizophrenic patients receiving clozapine or zotepine: results from a double-blind study. Pharmacopsychiatry 30:35-42.
20. Petit M, Raniwalla J, Tweed J, Leutenegger E, Dollfus S, Kelly F (1996) A comparison of an atypical and typical antipsychotic, zotepine versus haloperidol in patients with acute exacerbation of schizophrenia: a parallel-group double-blind trial. Psychopharmacol Bull 32:81-87.
21. Reus IV (1997) Olanzapine [author's reply]. Lancet 350:594.
22. Rosenheck R, Cramer J, Weichun BS, Thomas J, Henderson W, Frisman L et al. (1997) A comparison of clozapine and haloperidol in hospitalized patients with refractory schizophrenia. N Engl J Med 337:809-815.
23. Schulz KF, Chalmers I, Hayes RJ, Altman DG (1995) Empirical evidence of bias, JAMA 273:408-412.
24. Streiner DL (1990) Sample size and power in psychiatric research. Can J Psychiatry 35:616-620.
25. Tollefson GD, Beasley CM, Tran PV, Street JS, Krueger JA, Tamura RN, et al. (1997) Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial. Am J Psychiatry 154:457-465.
26. Tollefson GD, Sanger TM (1997) Negative symptoms: a path analytic approach to a double-blind, placebo-and haloperidol-controlled clinical trial with olanzapine. Am J Psychiatry 154:466-474.
27. Zimbroff DL, Kane JM, Tamminga CA, Daniel DG, Mack R, Wozniak PJ, et al. (1997) Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Am J Psychiatry 154:782-791.