Randomized controlled trials in schizophrenia: a critical perspective on the literature

Objective: The randomized trial provides an opportunity to minimize the inclusion of biases in the evaluation of interventions in psychiatry. Difficulties arise, however, when applying their results to 'real world' clinical practice and decision-making. We, therefore, examined the real world applicability of schizophrenia trials. Method: A narrative overview of the content and quality of the randomized trials relevant to the care of those with schizophrenia is provided. Results: Complex, explanatory, under-powered randomized drug trials dominate evaluative research in schizophrenia. Conclusion: Explanatory designs are a necessary but insufficient step in establishing the true worth of interventions in schizophrenia. Research from other spheres of mental health and wider health care suggest that pragmatic trials are feasible. This design allows large scale trials to be conducted which include patients which we would recognize from routine practice and which record outcomes which are of genuine interest to decision-makers.