The Use of Placebo in Clinical Trials on Bipolar Disorder: A New Approach for an Old Debate

The subject of the use of placebo in psychiatric clinical trials leads to very relevant ethical, methodological and clinical dilemmas. Many reasons support the use of placebo in acute bipolar studies, whereas in maintenance the length of the treatment with placebo makes the decision more difficult. Ethical concerns can be addressed through operational definitions of outcome measures, add-on and discontinuation designs, early escape strategies, and processes designed to make sure that fully informed consent was fairly obtained. There are a number of clinical and methodological variables that are associated with placebo response.