Balancing the Promise and Risks of Ketamine in 2020

A growing number of small but highly consistent controlled trials, case series, and anecdotal reports have demonstrated ketamine’s rapid and robust transient antidepressant properties. A meta-analysis of the published studies recently

completed by the American Psychiatric Association Council of Research Task Force on Novel Biomarkers and Treatments found the data from these studies to provide ‘compelling evidence that the antidepressant effects of ketamine infusion are both rapid and robust, albeit transient.’ (Newport et al, 2015). Although there are few reports examining the efficacy of repeated ketamine administration, those that have been published suggest the initial

the antidepressant effect can be extended over several weeks with repeated administrations (Murrough et al, 2013; Singh et al,

2016). Accounts of these findings have generated great interest in the media and optimism among patients. This has led to a growing number of clinics and practitioners who are

now offering various forms of Ketamine online treatment for mood and anxiety disorders throughout the United States, and a growing advocacy network that promotes the accessibility of the treatment. However, there is concern by some that the enthusiasm

engendered by these reports combined with the desperate the plight of the patients and their families may be leading to use

of ketamine in ways that are not yet adequately supported by the existing evidence. Although there is strong evidence that treatment with ketamine can provide significant short-term benefits to a large proportion of individuals suffering from serious, disabling, and potentially fatal mood disorders, the

treatment has not yet undergone the test of larger-scale clinical trials to demonstrate the durability and safety of the long-term treatment. Neither has the treatment approach been subjected to the scrutiny of a US FDA review. In addition, the growing abuse of ketamine in Asia and other areas of the world (Advisory Council on the Misuse of Drugs) has raised significant concerns over the potential for

fostering substance use disorders and drug diversion through broader use of ketamine in the treatment of depression.

Consequently, the medical field is now somewhat at odds over the expanding off-label use of ketamine in the treatment

of mood disorders.

A group of academic researchers, community clinicians, policymakers, and patient advocates recently convened to

discuss this topic. There was general agreement that

ketamine may be unique among available medications in its ability to rapidly help patients suffering from severe treatment-resistant depression, and given the known risks associated with prolonged severe major depressive episodes,

efforts should be made to further study the risks and benefits of the treatment and to support the responsible use of ketamine for treating carefully selected patients in appropriate settings. In order to best balance the promise of this

treatment and the potential risks associated with its widespread use in the clinical setting, we recommend that the following three steps should be taken without delay.

1. Creation of a Joint Statement from professional

organizations with expertise in related areas of study, providing a clear and concise overview of the state of the field. This statement should provide clinicians and patients with clear information based on the existing evidence on the efficacy and risks of ketamine treatment of mood disorders.

This information could be used to educate clinicians and assist in the informed consent process of prospective patients. The statement should also formulate some general

(minimal) standards of practice, based on existing data and the consensus of experts in the field, to afford some guidance to clinicians interested in providing the treatment option and assisting patients with referrals. This should include evaluation and screening criteria, safety considerations, and alternatives to such care.