Effect size of symptom status in withdrawal of typical antipsychotics and subsequent clozapine treatment in patients with treatment-resistant schizophrenia

American Journal of Psychiatry

Volumn 160, Issue 6, 2003, Pages 1133-1138

  Pickar, David ^a,b   Bartko, John J ^a  

^a Gabriel Pharma ^*  (United States)

^b Gabriel Pharma   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLOZAPINE; NEUROLEPTIC AGENT; PLACEBO;

ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG WITHDRAWAL; HUMAN; NEGATIVE SYNDROME; POSITIVE SYNDROME; PRIORITY JOURNAL; SCHIZOPHRENIA; TIME SERIES ANALYSIS; TREATMENT WITHDRAWAL; ADULT; BRIEF PSYCHIATRIC RATING SCALE; DRUG RESISTANCE; FEMALE; LONGITUDINAL STUDY; MALE; METHODOLOGY; PSYCHOLOGY; STATISTICAL ANALYSIS; STATISTICS; TREATMENT OUTCOME; WITHDRAWAL SYNDROME;

ADULT; ANTIPSYCHOTIC AGENTS; BRIEF PSYCHIATRIC RATING SCALE; CLOZAPINE; DATA INTERPRETATION, STATISTICAL; DOUBLE-BLIND METHOD; DRUG RESISTANCE; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; RESEARCH DESIGN; SCHIZOPHRENIA; SCHIZOPHRENIC PSYCHOLOGY; SUBSTANCE WITHDRAWAL SYNDROME; TREATMENT OUTCOME;

EID: 0038826191     PISSN: 0002953X     EISSN: None     Source Type: Journal    
DOI: 10.1176/appi.ajp.160.6.1133     Document Type: Article

References (36)

1. Rothman KJ, Michels KB: The continuing unethical use of placebo controls. N Engl J Med 1994; 331:394-398
2. Hyman SE, Shore D: An NIMH perspective on the use of placebos. Biol Psychiatry 2000; 47:689-691
3. Pinals DA, Applebaum PS: Ethical aspects of neuropsychiatric research with human subjects, in Neuropsychopharmacology: The Fifth Generation of Progress. Edited by Davis KL, Charney D, Coyle JT, Nemeroff C. Philadelphia, Lippincott Williams & Wilkins, 2002, pp 475-483
4. Beers MH, Berkow R (eds): Merck Manual of Diagnosis and Therapy, 17th ed. Whitehouse Station, NJ, Merck Research Laboratories, 1999, pp 1563-1571
5. Chakos M, Lieberman J, Hoffman E, Bradford D, Sheitman B: Effectiveness of second-generation antipsychotics in patients with treatment-resistant schizophrenia: a review and meta-analysis of randomized trials. Am J Psychiatry 2001; 158:518-526
6. Miyamoto S, Duncan GE, Goff DC, Lieberman JA: Therapeutics in schizophrenia, in Neuropsychopharmacology: The Fifth Generation of Progress. Edited by Davis KL, Charney D, Coyle JT, Nemeroff C. Philadelphia, Lippincott Williams & Wilkins, 2002, pp 775-807
7. Wyatt RJ: Risks of withdrawing antipsychotic medications. Arch Gen Psychiatry 1995; 52:205-208
8. Curson DA, Hirsch SR, Platt SD: Does short term placebo treatment of chronic schizophrenia produce long term harm? Br Med J (Clin Res Ed) 1986; 293:726-728
9. Carpenter WT, Tamminga CA: Why neuroleptic withdrawal in schizophrenia? Arch Gen Psychiatry 1995; 52:192-193
10. Baldessarini RJ, Viguera AC: Neuroleptic withdrawal in schizophrenic patients. Arch Gen Psychiatry 1995; 52:173-188
11. Jeste DV, Palmer BS, Harris MJ: Neuroleptic discontinuation in clinical and research settings: scientific issues and ethical dilemmas. Biol Psychiatry 1999; 46:1050-1059
12. Lieberman JA, Perkins D, Belger A, Chakos M, Jarskog F, Boteva K, Gilmore J: The early stages of schizophrenia: speculations on pathogenesis, pathophysiology, and therapeutic approaches. Biol Psychiatry 2001; 50:884-897
13. Wong DF, Potter WZ, Brasic JR: Proof of concept: functional models for drug development in humans, in Psychopharmacology: The Fifth Generation of Progress. Edited by Davis KL, Charney D, Coyle JT, Nemeroff C. Philadelphia, Lippincott Williams & Wilkins, 2002, pp 457-473
14. Pickar D, Rubinow K: Pharmacogenomics of psychiatric disorders. Trends Pharmacol Sci 2001; 22:75-83
15. Leber P: The use of placebo control groups in the assessment of psychiatric drugs: an historical context. Biol Psychiatry 2000; 47:699-706
16. Lavori PW: Placebo control groups in randomized treatment trials: a statistician's perspective. Biol Psychiatry 2000; 47:717-723
17. Klein DF, Thase M, Endicott J, Adler L, Glick I, Kalali A, Leventer S, Mattes J, Ross P, Bystritsky A: Improving clinical trials. Arch Gen Psychiatry 2002; 59:272-278
18. Dencker SJ, Malm U, Lepp M: Schizophrenic relapse after drug withdrawal is predictable. Acta Psychiatr Scand 1986; 73:181-185
19. Schreiber JL, Breier A, Pickar D: Characteristics of patients selected for treatment on a schizophrenia research ward. Hosp Community Psychiatry 1990; 41:441-443
20. Kane J, Honigfeld G, Singer J, Meltzer H (Clozaril Collaborative Study Group): Clozapine for the treatment-resistant schizophrenic: a double-blind comparison with chlorpromazine. Arch Gen Psychiatry 1988; 45:789-796
21. Pickar D, Owen RR, Litman R, Konicki E, Guiterez R, Rapaport MH: Clinical and biological response to clozapine in patients with schizophrenia. Arch Gen Psychiatry 1992; 49:345-353
22. Owen RR Jr, Gutierrez-Esteinou R, Hsiao J, Hadd K, Benkelfat C, Lawlor BA, Murphy DL, Pickar D: Effects of clozapine and fluphenazine treatment on responses to m-chlorophenylpiperazine infusions in schizophrenia. Arch Gen Psychiatry 1993; 50:636-644
23. Zahn TP, Pickar D: Autonomic effects of clozapine in schizophrenia: comparison with placebo and fluphenazine. Biol Psychiatry 1993; 34:3-12
24. 2 dopamine receptor occupancy in clozapine-treated patients. Am J Psychiatry 1996; 153:1571-1578
25. Cohen RM, Nordahl TE, Semple WE, Andreasen P, Litman RE, Pickar D: The brain metabolic patterns of clozapine and fluphenazine treated patients with schizophrenia during a continuous performance task. Arch Gen Psychiatry 1997; 54:481-486
26. Overall JE, Gorham DR: The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertaining and scaling. Psychopharmacol Bull 1988; 24:97-99
27. Cohen J: Statistical Power Analysis for the Behavioral Sciences, revised ed. New York, Academic Press, 1977
28. Conley RR, Kelly DL: Management of treatment resistance in schizophrenia. Biol Psychiatry 2001; 50:898-911
29. Rosenthal R: Meta Analytic Procedures for Social Research, revised ed. New York, Sage Publications, 1991
30. Kane JM: Issues in clinical trials designs, in Neuropsychopharmacology: The Fifth Generation of Progress. Edited by Davis KL, Charney D, Coyle JT, Nemeroff C. Philadelphia, Lippincott Williams & Wilkins, 2002, pp 537-546
31. Perkins DO, Wyatt RJ, Bartko JJ: Penny-wise and pound-foolish: the impact of measurement error on sample size requirements in clinical trials. Biol Psychiatry 2000; 47:762-766
32. McMahon RP, Kelly DL, Kreyenbuhl J, Kirkpatrick B, Love RC, Conley RR: Novel factor-based symptom scores in treatment resistant schizophrenia: implications for clinical trials. Neuropsychopharmacology 2002; 26:537-545
33. Marder SR, Meilbach RC: Risperidone in the treatment of schizophrenia. Am J Psychiatry 1994; 151:825-835
34. Beasley CM, Tollefson G, Tran P, Satterliee W, Sanger T, Hamilton S: Olanzapine versus placebo and haloperidol. Neuropsychopharmacology 1996; 14:111-123
35. Jeste DV, Palmer BS, Harris MJ: Neuroleptic discontinuation in clinical and research settings: scientific issues and ethical dilemmas. Biol Psychiatry 1999; 46:1050-1059
36. Gilbert PL, Harris MJ, McAdams A, Jeste DV: Neuroleptic withdrawal in schizophrenia: a review of the literature. Arch Gen Psychiatry 1995; 52:173-188