Clinical Trials in Psychiatry, 2nd 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.