WE APPRECIATE Dr Calabrese's commentary on our study of ω3 fatty acids as a new treatment of bipolar disorder. He correctly points out both the exciting aspects of ω3 fatty acids as a therapy for patients with bipolar disorder, as well as the methodological shortcomings of our preliminary trial.
Dr Calabrese's constructive criticisms of the study methodology are reasonable and are issues that future studies should address. When evaluating the methods for our current study, it is important to keep in mind that this was a preliminary study designed to demonstrate the prophylactic efficacy of ω3 fatty acids as mood stabilizers. It was intended to be a longer-term trial, but 2 factors led to premature termination of the study. First, the preplanned 4-month interim data analysis revealed an unacceptably high relapse rate among the patients receiving placebo, which led us to conclude that it would be more ethical to stop the pilot study, and evaluate the available data. In addition, a shortage of study drug from the National Institutes of Health would have forced a later, but still premature, termination of the study.