El papel del placebo en ensayos clínicos en esquizofrenia

In recent years, there appears to be a trend towards an increasing placebo response rate and decreasing signal detection of new treatments in clinical trials of antipsychotics in schizophrenia. This has been also observed in patients with major depressive disorder. Since the use of placebo in research remains the only valid formula to demonstrate the effectiveness of new treatments, despite the ethical aspects of the use of placebo, it is necessary to investigate what mechanisms influence this trend. The aim of this review is to find out why this trend is occurring and what can be done to counter it. For this purpose, we review relevant aspects in the design and development of clinical trials in schizophrenia. We will also propose new design models that may help to define the validity of the response rates of placebos, which are being implemented in recent years in clinical trials to demonstrate the efficacy of new treatments in patients with schizophrenia.