Off-Label Use of Ketamine for the Treatment of Patients With Mood Disorders

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synapse and neuron cells
Ketamine dosing continues to raise safety concerns.

Patients with mood disorders that are refractory to standard therapies may be candidates for the off-label use of ketamine. According to a report published in JAMA, although ketamine has been approved by the US Food and Drug Administration for use as an anesthetic for more than 45 years, concerns persist regarding the safety of repeated ketamine dosing. Some of these concerns have arisen from reports of cognitive impairment and bladder dysfunction associated with repeated ketamine administration. Restricted use of the agent until additional data become available has been recommended.

The American Psychiatric Association Council of Research Task Force on Novel Biomarkers and Treatments recently issued a consensus statement on the off-label use of ketamine for the treatment of mood disorders. The consensus contributors emphasized that patient selection is key to optimizing the risk-to-benefit ratio of ketamine therapy. Because limited long-term efficacy and safety data are available, only those individuals who have not responded to more standard antidepressant therapies should be candidates for ketamine treatment.

According to the consensus statement, the treatment facility should have in place a means of providing basic cardiac and respiratory monitoring. Certification in Advanced Cardiac Life Support (ACLS) is recommended for clinicians who administer ketamine. To ensure patient safety, site-specific standard operating procedures should be developed.

To date, most available evidence has favored treatment with ketamine hydrochloride
at a dose of 0.5 mg/kg administered intravenously over 40 minutes. Clinicians should limit the administration of ketamine for mood disorders to the minimum effective dosing frequency, and they should monitor cognition, bladder function, and substance use. Take-home, self-administration is not advised.

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The researchers concluded that the enthusiasm surrounding the use of ketamine among patients with mood disorders must be coupled with extreme caution. The creation of a registry of patients receiving off-label ketamine for mood disorders may be beneficial.


Wilkinson ST, Sanacora G. Considerations on the off-label use of ketamine as a treatment for mood disorders. JAMA. 2017;318:793-794. doi: 10.1001/jama.2017.10697