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  • Chapter 7 - Clinical Trials

  • from Section 2 - Tools and Methodologies
  • Edited by Dawn N. Albertson, University of New Hampshire, Derek K. Tracy, South London and Maudsley NHS Foundation Trust, Dan W. Joyce, University of Liverpool, Sukhwinder S. Shergill, Kent and Medway Medical School
  • Book:
    Research Methods in Mental Health
    Published online:
    31 October 2025
    Print publication:
    20 November 2025, pp 95-110

  • Summary

    Clinical trials are a cornerstone of evaluating new interventions. Although there are similarities between clinical trials across medical specialties there are specific issues that need to be considered when designing, running and evaluating clinical trials in mental health. The purpose of this chapter is to present an overview of the common principles and methods of interventional clinical trials with illustrations drawn from general psychiatry. The chapter provides a guide to understanding clinical trials from design to analysis, drawing on recent work to illustrate fundamental concepts and covers novel factorial and platform designs. outlining advantages and disadvantages of each. This chapter summarises essential steps of interventional clinical trials in psychiatry describing the process from initial hypothesis generation, the role of patient and public involvement, steps to prepare a trial protocol, statistical considerations dissemination of results. The aim is to provide the reader with the tools to be able to understand different methodologies and in design of clinical trial in mental health.