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Methodology of the Evaluation of Psychotropic Drugs

  • Conference proceedings
  • © 1990

Overview

Editors:
  1. Otto Benkert
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  2. Wolfgang Maier

    1. Psychiatrische Klinik und Poliklinik, Klinikum der Johannes Gutenberg-Universität Mainz, Mainz, Germany

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  3. Karl Rickels

    1. Department of Psychiatry, University of Pennsylvania, Philadelphia, USA

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Part of the book series: Psychopharmacology Series (PSYCHOPHARM, volume 8)

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Table of contents (13 papers)

  1. Front Matter

    Pages I-XI
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  2. State of the Art in Drug Trials

    1. Front Matter

      Pages 1-1
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    2. Evaluating Antidepressants and Anxiolytics

      • K. Rickels
      Pages 3-25

    3. Testing the Efficacy of New Neuroleptic Drugs

      • S. R. Hirsch, T. R. E. Barnes
      Pages 26-36

    4. Evaluation of Drugs in Alzheimer’s Disease and Age-Associated Memory Impairment

      • T. H. Crook, B. A. Johnson, G. J. Larrabee
      Pages 37-55

    5. Testing the Efficacy of New Hypnotic Drugs

      • F. Hohagen, M. Berger
      Pages 56-69

  3. Placebo-Controlled Trials and Ethical Issues

    1. Front Matter

      Pages 71-71
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    2. Placebo-Controlled Studies in Depression: Necessity and Feasibility

      • E. S. Paykel
      Pages 73-81

    3. Ethical Problems and Design of Controlled Clinical Trials

      • H. Helmchen
      Pages 82-87

  5. Selection Criteria for Drug Trials

    1. Front Matter

      Pages 137-137
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    2. Diagnoses as Selection Criteria in Drug Trials

      • R. Buller, W. Maier
      Pages 139-154

    3. Functional Classification and Response to Psychotropic Drugs

      • O. Benkert
      Pages 155-163

  6. Appendix

    1. Front Matter

      Pages 165-165
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    2. National and International Guidelines for the Conduct of Clinical Trials of Psychotropic Drugs

      • B. Müller-Oerlinghausen
      Pages 167-174

  7. Back Matter

    Pages 175-191
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Keywords

About this book

The idea of placebo-controlled drug trials and the advent of test statistics during the first part of this century were the major milestones in the establishment of a convincing methodology for demonstrating the efficacy of treatments. The first tricyclic and neuroleptic drugs were tested for their efficacy in psychiatric disorders along the lines of these methodological developments, but subsequent trials with psychotropic drugs did not adhere to these principles to the same extent because it became difficult to justify placebo-controlled trials once effective treatments had been established. Consequently, the second generation of an­ tidepressants and neuroleptics (since the early 1960s) were mainly tested, in Europe at least, in samples of patients using trials controlled by standard treatment only, and the methodological basis of these second generation trials became fragile, as will be demonstrated by several papers in this book. This development did not provoke much discussion until recently, when scientific and administrative interest in the methodology of the evaluation of psychotropic drugs increased substantially. A series of factors contribute to the growing interest in the standards of psychotropic drug trials: 1. The proportion of psychiatric patients resistant to treatment is growing; the efficacy of well-established forms of treatment therefore seems to be limited. 2. A series of psychotropic drugs were withdrawn from the market, mainly because they caused serious side effects. The efficacy and safety ofthese drugs had previously been demonstrated in drug trials, which raised the question whether the drug trials carried out were well-designed.

Editors and Affiliations

  • Psychiatrische Klinik und Poliklinik, Klinikum der Johannes Gutenberg-Universität Mainz, Mainz, Germany

    Wolfgang Maier

  • Department of Psychiatry, University of Pennsylvania, Philadelphia, USA

    Karl Rickels

Bibliographic Information

  • Book Title: Methodology of the Evaluation of Psychotropic Drugs

  • Editors: Otto Benkert, Wolfgang Maier, Karl Rickels

  • Series Title: Psychopharmacology Series

  • DOI: https://doi.org/10.1007/978-3-642-75370-1

  • Publisher: Springer Berlin, Heidelberg

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer-Verlag Berlin Heidelberg 1990

  • Softcover ISBN: 978-3-642-75372-5Published: 13 December 2011

  • eBook ISBN: 978-3-642-75370-1Published: 06 December 2012

  • Series ISSN: 0931-6795

  • Edition Number: 1

  • Number of Pages: XI, 191

  • Number of Illustrations: 1 b/w illustrations

  • Topics: Psychiatry

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