Treating Bipolar Depression Using Psilocybin —Validity Threats Regarding Efficacy and Safety—Reply

In Reply We thank Fried et al for their thoughtful remarks about our article. The first issue they raised concerned the description of our study as a nonrandomized controlled trial. This could be problematic, as there was no comparator group or other control for non-specific effects. However, the nature of the study design was clearly described in the article and the accompanying editorial, which stated, “Aaronson and colleagues present an important step forward in this single-arm open-label study of psilocybin in patients with bipolar II depression.” We elected to use the phrase “controlled trial” to reflect the stringency of participant selection and the prohibitions on other psychotropic drugs before and after psilocybin dosing. However, to avoid confusion, we agree to amend the subtitle to a nonrandomized open-label trial.
Source: JAMA Psychiatry - Category: Psychiatry Source Type: research