Clinical Trials in Psychiatry

Brian S. Everitt. Professor of Behavioural Statistics, Department of Biostatistics and Computing, Institute of Psychiatry, King’s College, London, UK. Simon Wessely. Professor of Epidemiological and Liaison Psychiatry Director, King's Centre for Military Health Research, Institute of Psychiatry, King’s College, London, UK; Department of Psychological Medicine, Weston Education Centre, London, UK.

• Preface to the first edition. Preface to the second edition.1. Treatments, good, bad or worthless – and how do we tell?1.1 Treatments worthless – and worse.1.2 A brief history of treating the mentally ill.1.3 Summary.2. The randomized clinical trial.2.1 Introduction.2.2 The clinical trial.2.3 Ethical issues in clinical trials.2.4 Informed consent.2.5 Compliance.2.6 Summary.3. Design issues in clinical trials.3.1 Introduction.3.2 Clinical trial designs.3.3 Methods of randomization.3.4 Methods of masking treatments.3.5 The size of a clinical trial.3.6 Interim analysis.3.7 Summary.4. Special problems of trials in psychiatry.4.1 Introduction.4.2 Explanatory versus pragmatic trials.4.3 Complex interventions.4.4 Outcome measures in psychiatry.4.5 Summary.5. Some statistical issues in the analysis of psychiatric trials.5.1 Introduction.5.2 P-values and confidence intervals.5.3 Using baseline data.5.4 Longitudinal data.5.5 Missing values and dropouts in longitudinal data.5.6 Multiple outcome measures.5.7 Intention-to-treat.5.8 Economic evaluation of trials.5.9 Number needed to treat.6. Analysing data from a psychiatric trial: an example.6.1 Introduction.6.2 Beating the Blues.6.3 Analysis of the post-treatment BDI scores.6.4 Graphical displays and summary measure analysis of longitudinal data.6.5 Random effects models for the BtB data.6.6 The dropout problem in the BtB data.6.7 Summary.7. Systematic reviews and meta-analysis.7.1 Introduction.7.2 Study selection.7.3 Publication bias.7.4 The statistics of meta-analysis.7.5 Some examples of meta-analysis of psychiatric trials.7.6 Summary.8. RCTs in psychiatry: threats, challenges and the future.8.1 Introduction.8.2 Can randomized clinical trials in psychiatry be justified?8.3 Are randomized clinical trials really necessary?8.4 Conflicts of interest.8.5 Scandals, trials and tribulations.8.6 The future of psychiatric trials.8.7 Defending the clinical trial.8.8 Summary.Appendix A.  Issues in the management of clinical trials- 'how to do it'.A.1 Introduction.A.2 Clinical trial protocols.A.3 Getting the costs right.A.4 Collecting and managing the data.A.5 Writing the patient information sheet.A.6 Getting informed consent.A.7 Maintaining recruitment.A.8 Useful web sites.Appendix B. Writing a trial report.B.1 Introduction.Appendix C. Useful software for clinical trials.C.1 Introduction.C.2 Data management.C.3Design.C.4 Analysis.Bibliography.Index.

"A book to read from beginning to end.... Clinical Trials in Psychiatry covers all the most important issues and will be useful to all clinicians who are involved in conducting, or using the results of, clinical trials. It provides a highly persuasive account of the unique scientific advantages of randomised trials for those who remain unconvinced. It is very readable." (British Journal of Psychiatry, February 2009) "On balance, readers looking for a practical text to introduce them to the key issues will be well-satisfied with Clinical Trials in Psychiatry." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)"On balance, readers looking for a practical text to introduce them to the key issues will be well-satisfied with Clinical Trials in Psychiatry." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)