Magazine article Clinical Psychiatry News

Guidance on Ketamine: APA Task Force Backs Restraint on Using Drug off Label for Mood Disorders

Magazine article Clinical Psychiatry News

Guidance on Ketamine: APA Task Force Backs Restraint on Using Drug off Label for Mood Disorders

Article excerpt

[ILLUSTRATION OMITTED]

A new consensus statement on the use of ketamine as an off-label treatment for mood disorders provides psychiatrists some guidance for patient selection and evaluation, as well as dosing and duration of therapy. The statement was issued against the backdrop of newer studies showing ketamine's rapid, though not durable, efficacy in treating depression and anxiety disorders.

From start to end, however, the statement urges caution and marks out areas for further study, citing a paucity of data on longer-term efficacy and safety and a literature largely made up of smaller studies.

In the statement, developed by the American Psychiatric Association Council of Research Task Force on Novel Biomarkers and Treatments: Subgroup on Treatment Recommendations for Clinical Use of Ketamine, lead author Gerard Sanacora, MD, PhD, noted that, although ketamine has been used for more than 45 years as an anesthetic, there has been no postmarketing surveillance of its use in psychiatry, prompting an "urgent need for some guidance on issues surrounding the use of ketamine treatment in mood disorders" (JAMA Psychiatry. 2017 Mar 1. doi: 10.1001/jamapsychiatry.2017.0080).

Dr. Sanacora, professor of psychiatry at Yale University, New Haven, Conn., and his coauthors made clear that "this report is not intended to serve as a standard, guideline, clinical policy, or absolute requirement." Rather, the document identifies the current state of the field and identifies factors to consider in determining the appropriateness of ketamine therapy.

When a clinician is considering giving ketamine to a patient, a preprocedural evaluation is recommended, both to assess whether ketamine is likely to benefit the patient and to evaluate potential risks. Recommended components include a comprehensive psychiatric diagnostic assessment, paying particular attention to substance use and psychosis history, if any; assessment of baseline symptom severity; history of prior antidepressant treatment; review of systems to assess risk factors; physical examination and laboratory screening that follows accepted guidelines for the anticipated level of sedation, with the recommended addition of a baseline urine toxicology screen; and records review and family corroboration with a particular eye to past substance use.

Finally, the informed-consent process should ensure that the patient is aware not only of potential treatment risks but also of the relatively limited data on the off-label use of ketamine for mood disorders. Thorough written documentation is recommended.

Regarding the appropriate amount of experience and training a clinician should have before administering ketamine. Dr. Sanacora and his coauthors noted that the subanesthetic doses of ketamine that are used to treat mood disorders have been found generally very safe in the limited studies that have been done. Typical peak plasma concentrations will not induce general anesthesia. However, systolic and diastolic blood pressure and heart rate elevations are not uncommon. The statement cites a study that found "blood pressure levels exceeding 180/100 mm Hg or heart rates exceeding 110 beats per minute in approximately 30% of the patients treated."

Accordingly, the statement recommends that clinicians administering ketamine have Advanced Cardiac Life Support certification and be able to administer Drug Enforcement Administration Schedule III medications. …

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