The Importance of a Valid Comparison Group

Abstract

this is the optimal or correct dose to be used for the treatment of mood disorders.As correctly noted, all treatment with ketamine remains off-label and supported by limited published data. When more data become available on alternative dosing strategies, such as the soon-to-be-released results of the National Institutes of Health-funded RAPID study (NCT01920555), we will be able to provide a more informed statement on dosing. However, until such information is available, we believe that potential patients should be made aware of the fact that most published reports citing ketamine's antidepressant effects to date have used the 0.5-mg/kg dose provided over 40 minutes as part of an informed consent process, and that clinicians weigh this fact in their consideration of using alternative doses. We are not calling for a special informed consent process when using alternative ketamine dosing strategies, but a comprehensive informed consent process for all patients considering the treatment.As highlighted in the recent publications by Kraus et al 4 and Singh et al, 5 we agree with the importance of acknowledging established ethical and legal frameworks, in addition to the available scientific information, when considering the use of ketamine therapy. We especially agree with the call to use the virtue of humility in acknowledging the uncertainties that accompany the use of this novel treatment strategy.We also agree with Golzari and Mahmoodpoor regarding the need for special considerations to be made for specific medical conditions. We sought to provide the most accurate and complete information available in the consensus statement and acknowledge the limitations of this information. We encourage clinicians to do the same when providing informed consent and treating patients. We support the formation of a national or international registry to advance our knowledge of the treatment, and thus allow for the development of more specific and meaningful guidelines in the near future.