Methodology of the Evaluation of Psychotropic Drugs

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

4. Biostatistics and Measurement of Drug Effects

   1. Front Matter

      Pages 89-89

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   2. Statistical Issues: Sample Size and Dropout

      • P. Lavori

      Pages 91-104

   3. Measuring the Efficacy of Psychotropic Drugs: Clinical Symptoms and Rating Scales

      • W. Maier, P. Bech

      Pages 105-120

   4. Methodological Problems in Assessing Quality of Life as Outcome in Psychopharmacology: A Multiaxial Approach

      • P. Bech

      Pages 121-129

   5. Ascertainment of Side Effects in Psychopharmacologic Clinical Trials

      • J. Levine

      Pages 130-135

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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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.

• Alzheimer's disease
• Alzheimer´s disease
• clinical trial
• depression
• development
• diagnosis
• drug
• memory
• pharmacology
• psychiatric disorder
• psychopharmacology
• quality of life
• safety
• statistics
• treatment

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

  Wolfgang Maier

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

  Karl Rickels

Policies and ethics