Hostname: page-component-cd9895bd7-q99xh Total loading time: 0 Render date: 2024-12-26T18:16:59.009Z Has data issue: false hasContentIssue false
  • English
  • Français

Long-term studies of antipsychotic drugs in schizophrenia

Published online by Cambridge University Press:  16 April 2020

T Lewander
T Lewander*
Affiliation:
Astra Arcus AB, Project Planning and Coordination, Södertälje, and Department of Psychiatry (Ullerdker), University of Uppsala, Uppsala, Sweden
*
*Correspondence and reprints: T Lewander, Project Planning and Coordination, Astra Areus AB, S-15185 Södertälje, Sweden.
Get access

Summary

Studies on long-term efficacy and safety should be a main concern in the evaluation of novel antipsychotics. The present paper is a review of important issues related to the design and performance of such trials. The variability of the natural course of schizophrenia, the variability in treatment response, and the variability of actions of different neuroleptics need to be considered. Long-term studies need to address maintenance of efficacy, prevention of relapse and recurrence, health economics, quality of life and a large number of safety issues in order to get approval for new drug applications and reimbursement on expensive new medicines. Assessment instruments for efficacy, tolerability and safety, need to be supplemented with rating scales for various aspects of psychopathology (positive, negative, deficit symptoms), social and work functioning, drug induced mental side effects, quality of life and accounts of total treatment costs.

Keywords

neurolepticsantipsychoticslong-term treatmentschizophreniarating scalesrandomized controlled trials
Type
Research Article
Information
European Psychiatry , Volume 11 , Issue 3: Issues of Concern in the Standardization and Harmonization of Psychotropic Drug Trials in Europe , 1996 , pp. 127 - 134
Copyright
Copyright © Elsevier, Paris 1996

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

American Psychiatric Association Diagnostic and statistical manual of mental disorders. DSM-IV. Houten: APA, 1994Google Scholar
Andreasen, NCThe scale for assessment of negative symptoms (SANS). Washington DC: The University of Iowa, 1983Google Scholar
Andreasen, NCThe scale for assessment of positive symptoms (SAPS). Iowa City: University of Iowa, 1984Google Scholar
Åsberg, M, Montgomery, S, Perris, C, Schalling, D, Sedvall, GThe comprehensive psychopathological rating scale (CPRS) development and applications of a psychiatric rating scale. Acta Psychiatr Scand 58suppl 2711978 1–27Google Scholar
Barnes, TRE, Edwards, JGSide effects of antipsychotic drugs. I CNS and neuromuscular effects. In: Barnes, TRE eds. Anti-psychotic drugs and their side effects. Iowa City: Academic Press, 1993; 213–248CrossRefGoogle Scholar
Beck, P, Malt, UF, Dencker, SJ, et al.Scales for assessment of diagnosis and severity of mental disorders Acta Psychiatr Scand 1993 87 suppl 372 1–87Google Scholar
Bleuler, MThe schizophrenic disorders In: Long-term patient and family studies. London: Yale University Press, 1978Google Scholar
Brown, GW, Birley, LT, Wing, JKInfluence of family life on the course of schizophrenic disorders: a replication. Br J Psychiatry 1972; 121: 241–258CrossRefGoogle ScholarPubMed
Crow, TJ, MacMillan, JF, Johnson, AL, Johnstone, ECThe Northwick Park study of first episodes of schizophrenia II. A randomized controlled trial of prophylactic neuroleptic treatment. Br J Psychiatry 1986; 148: 120–127CrossRefGoogle Scholar
Carpenter, WT, Heinrichs, DW, Wagman, AMIDeficit and non-deficit forms of schizophrenia: the concept. Am J Psychiatry 1988; 145: 578–583Google Scholar
Ciompi, LLearning from outcome studies. Toward a comprehensive biological-psychosocial understanding of schizophrenia. Schizophr Res 1988; 1: 373–384CrossRefGoogle Scholar
Ciompi, L, Müller, CLebensweg und Alter der Schizophrenen. Ein katamnestische Langzeitstudie bis ins Senium. New Haven, London: Springer-Verlag, 1976CrossRefGoogle Scholar
Chouinard, G, Ross-Chouinard, A, Annable, L, et al.Extrapyramidal symptom rating scale Can J Neurol Sci 1980 7 233Google Scholar
Davis, JM, Andriukaitis, SThe natural course of schizophrenia and effective maintenance drug treatment. J Clin Psychopharmacol 1986; 6: 2S10SCrossRefGoogle ScholarPubMed
Delini-Stula, A, Berdah-Tordjman, DPlacebo controlled studies in acute schizophrenia - an issue of concern. Eur Psychiatry 1994; 9: 165–173CrossRefGoogle Scholar
Dilsaver, SC, Alessi, NEAntipsychotic withdrawal symptoms: phenomenology and pathophysiology. Acta Psychiatr Scand 1988; 77: 241–246CrossRefGoogle ScholarPubMed
Edwards, JG, Barnes, TREThe side-effects of antipsychotic drugs. II. Effects on other physiological systems. In: Barnes, TRE eds. Antipsychotic drugs and their side effects. Berlin, Heidelberg, New York: Academic Press, 1993; 249–276CrossRefGoogle Scholar
Emerich, DF, Sandberg, PRNeuroleptic dysphoria. Biol Psychiatry 1991; 29: 201–203CrossRefGoogle ScholarPubMed
Endicott, J, Spitzer, RL, Fleiss, JL, Cohen, GThe global assessment scale. Arch Gen Psychiatry 1976; 33: 766–771CrossRefGoogle ScholarPubMed
Frank, E, Prien, RF, Jarret, RB, et al.Conceptualization and rationale for consensus definitions of terms in major depressive disorder Arch Gen Psychiatry 1991 48 851–855CrossRefGoogle ScholarPubMed
Goldberg, SCNegative and deficit symptoms in schizophrenia do respond to neuroleptics. Schizophr Bull 1985; 11: 453–456CrossRefGoogle ScholarPubMed
Guy, WECDEU assessment manual for psychopathology. London: Department of Health, Education and Welfare, 1976Google Scholar
Harding, CM, Brooks, GW, Ashikaga, T, Strauss, JS, Breier, AThe Vermont longitudinal study of persons with severe mental illness. I. Methodology, study sample, and overall status 32 years later. Am J Psychiatry 1987; 144: 718–726Google ScholarPubMed
Hegarty, JD, Baldessarini, RJ, Tohen, M, Waternaux, C, Oepen, GOne hundred years of schizophrenia: a meta-analysis of the outcome literature. Am J Psychiatry 1994; 151: 1409–1416Google ScholarPubMed
Huber, G, Gross, G, Schüttler, RSchizophrenie. Verlaufs- und sozialpsychiatrische Langzeituntersuchungen an den 1945–1959 in Bonn hospitalisierten schizophrenen Kranken. Washington DC: Springer-Verlag, 1979Google Scholar
ICD-10 The ICD-10 classification of mental and behavioural disorders. Clinical descriptions and diagnostic guidelines. Berlin, New York: World Health Organization, 1992Google Scholar
Kane, JM, Honigfeld, G, Singer, J, Meltzer, H, et al.Clozapine for the treatment resistant schizophrenic Arch Gen Psychiatry 1988 45 789–796CrossRefGoogle ScholarPubMed
Kane, JM, Lieberman, JAMaintenance pharmacotherapy in schizophrenia. In: Meltzer, HY eds. Psychopharmacology: the third generation of progress. Geneva: Raven Press, 1987; 1103–1109Google Scholar
Kaufmann, CA, Wyatt, RJNeuroleptic malignant syndrome. In: Meltzer, HY eds. Psychopharmacology: The third generation of progress. New York: Raven Press, 1987; 1421–1429Google Scholar
Kay, SRPositive and negative syndromes in schizophrenia. Assessment and research. New York: Brunner/Mazel, 1991Google Scholar
Kellam, AMPThe neuroleptic malignant syndrome, so-called. A survey of the world literature. Br J Psychiatry 1987; 150: 752–759CrossRefGoogle ScholarPubMed
King, DJ, Blomqvist, M, Cooper, SJ, Doherty, MM, Mitchell, MJ, Montgomery, RCA placebo controlled trial of remoxipride in the prevention of relapse in chronic schizophrenia. Psychopharmacology 1992; 107: 175–179CrossRefGoogle ScholarPubMed
Kirkpatrick, B, Buchanan, RW, McKenney, PD, Alphs, LD, Carpenter, WR JrThe schedule for the deficit syndrome: an instrument for research in schizophrenia. Psychiatr Res 1989; 30: 113–119CrossRefGoogle Scholar
Klein, DF, Davis, JMReview of the antipsychotic drug literature. In: Klein, DF, Davis, JM eds. Diagnosis and drug treatment of psychiatric disorders. New York: The Williams & Wilkins Company, 1969; 52–138Google Scholar
Krawiecka, M, Goldberg, D, Vaughan, MA standdardized psychiatric assessment scale for rating chronic psychotic patients. Acta psychiatr scand 1977; 55: 299–308CrossRefGoogle ScholarPubMed
Lewander, TPlacebo response in schizophrenia. Eur Psychiatry 1994; 9: 119–120CrossRefGoogle Scholar
Lewander, TNeuroleptics and the neuroleptic induced deficit syndrome. Acta Psychiatr Scand 89suppl 3801994 8–13CrossRefGoogle Scholar
Lewander, TPatient sampling: problems of generalization of findings in schizophrenia. Discussion. Eur Psychiatry 1994; 9: 141–142CrossRefGoogle Scholar
Lewander, T, Westerbergh, SE, Ogenstad, S, Gustafsson, BRemoxipride and haloperidol in acute phase schizophrenia - experiences from a recent clinical trial programme. In: Brunello, N, Mendlewicz, J, Racagni, G eds. New generation of antipsychotic drugs: novel mechanimsms of action 4 Baltimore: Int Acad Biomed Res, 1993; 97–102Google Scholar
Lindström, JHLong-term clinical and social outcome studies in schizophrenia in relation to the cognitive and emotional side effects of antipsychotic drugs. Acta Psychiatr Scand 1994 89 suppl 380 74–76CrossRefGoogle Scholar
Lingj˦rde, O, Ahlfors, UG, Beck, P, Dencker, SJ, Elgen, KA new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand 76suppl 3341987Google Scholar
N von, Luckner, Maurer, M, Kuny, S, Woggon, B, Dittrich, AA comparison of AMDP system and comprehensive psychiatric rating scale with regard to contents. Neuropsychobiol 1985; 13: 117–120Google Scholar
Manning, C, Gengo, FMEffects of drugs on human functioning: antihistamines. In: Streufers, S, Gengo, FM eds. Effects of drugs on human functioning 9 Karger, Basel: Prog Basic Clin Pharmacol, 1993; 52–69Google Scholar
Marneros, A, Andreasen, NC, Tsuang, MTNegative versus Positive Schizophrenia. Karger, Basel: Springer-Verlag, 1991CrossRefGoogle Scholar
Meltzer, HY, Sommers, AA, Luchins, DJThe effects of neuroleptics and other psychotropic drugs on negative symptoms in schizophrenia. J Clin Psychopharmacol 1986; 6: 329–338CrossRefGoogle Scholar
Montgomery, SA, Taylor, P, Montgomery, DDevelopment of a schizophrenia scale sensitive to change. Neuropharmacology 1978; 17: 1061–1063CrossRefGoogle ScholarPubMed
Möller, H-JNeuroleptic treatment of negative symptoms in schizophrenic patients. Efficacy problems and methodological difficulties Eur Neuropsychopharmacol 1993; 3: 1–11CrossRefGoogle ScholarPubMed
Möller, HJ, von Zerssen, DCourse and outcome of schizophrenia. In: Hirsch, SR, Weinberger, DR eds. Schizophrenia. Berlin, Heidelberg, New York: Blackwell Science, 1955; 106–127Google Scholar
Naber, DSubjective effects of neuroleptics - they predict compliance and should be considered more in clinical trials Neuropsychopharmacology 1994a 10/3S/Part 1 630SGoogle Scholar
Naber, DSubjective effects of neuroleptics predict compliance. In: Gaebel, W, Awad, GR eds. Prediction of Neuroleptic Treatment Outcome in Schizophrenia Concepts and Methods. Oxford: Springer-Verlag, 1994; 85–91CrossRefGoogle Scholar
Overall, JE, Gorham, DRThe brief psychiatric rating scale. Psychol Rep 1962; 10: 799–812CrossRefGoogle Scholar
Pietzcher, A, Gaebel, W, Köpcke, W, et al.Intermittent versus maintenance neuroleptic long-term treatment in schizophrenia - 2 year results of a German multicenter study J psychiat Res 1993 27 321–339CrossRefGoogle Scholar
Pope, HG Jr, Keck, PE, McElroy, SLFrequency and presentation of neuroleptic malignant syndrome in a large psychiatric hospital. Am J Psychiatry 1986; 143: 1227–1233Google Scholar
Prien, RF, Carpenter, LL, Kupfer, DJThe definition and operational criteria for treatment outcome of major depressive disorder. A review of current research literature. Arch Gen Psychiatry 1991; 48: 796–800CrossRefGoogle ScholarPubMed
Reynolds, GPAntipsychotic drug mechanisms and neurotransmitter systems in schizophrenia. Acta Psychiatr Scand 89suppl 3801994 36–40CrossRefGoogle Scholar
Schooler, N, Kane, JMResearch diagnoses for tardive dyskinesia (RD-TD). Arch Gen Psychiatry 1982; 39: 486–487Google Scholar
Simpson, GM, Angus, JWSA rating scale for extrapyramidal side effects. Acta Psychiatr Scand 45suppl 2121979 11–19CrossRefGoogle Scholar
Strauss, JS, Carpenter, WT JrThe prediction of outcome in schizophrenia: I: Characteristics of outcome. Arch Gen Psychiatry 1972; 27: 739–746CrossRefGoogle Scholar
Wolkin, A, Barouche, F, Wolf, AP, et al.Dopamine blockade and clinical response: evidence for two biological subgroups of schizophrenia Am J Psychiatry 1989 146 905–908Google ScholarPubMed
Vaughn, CE, Leff, JPThe measurement of expressed emotion in the families of psychiatric patients. Br J Soc Clin Psychol 1976; 15: 157–165CrossRefGoogle ScholarPubMed
Vaughn, CE, Leff, JPThe influence of family and social factors on the course of psychiatric illness: a comparison of schizophrenic and depressed neurotic patients. Br J Psychiatry 1976; 129: 125–137CrossRefGoogle ScholarPubMed
Warner, RRecovery from schizophrenia. Psychiatry and Political Economy. Heidelberg: Routledge, 1994Google Scholar
Wyatt, RJNeuroleptics and the natural course of schizophrenia. Schiz Bull 1991; 17: 325–351CrossRefGoogle ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.