Researcher Urges Caution When Prescribing Ketamine for Depression

In an article published in JAMA (Journal of the American Medical Association) Psychiatry, University of Miami Miller School of Medicine psychiatrist Charles B. Nemeroff, M.D., Ph.D., joins colleagues in warning that physicians should carefully weigh the risks and potential benefits before prescribing ketamine as a treatment for depression.

“Physicians should try well-established treatments for depression, including FDA-approved medications and evidence-based psychotherapies, before turning to this novel approach,” said Nemeroff, who is the Leonard M. Miller Professor and chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami Health System.

The article, “A Consensus Statement on the Use of Ketamine Hydrochloride in the Treatment of Mood Disorders,” listed recommendations from the American Psychiatric Association’s research council regarding ketamine:

• Every patient should receive a thorough psychiatric evaluation to determine the diagnosis and any substance-abuse issues or psychotic disorders.

• Ketamine should only be prescribed for patients with clinical depression, not for personality disorders or other conditions.

• Ketamine should not be prescribed to patients with a history of substance or alcohol use, and a baseline urine toxicology screen is recommended.

• Patients should be informed about current FDA-approved treatments and consent to the use of ketamine.

• Physicians should monitor their patients carefully for side effects, including hypertension and cardiovascular problems.

• Prescribing physicians should be trained in advanced cardiopulmonary resuscitation procedures and be able to respond to any medical emergencies.

Ketamine is approved by the FDA for anesthesia, and has recently been studied for off-label use in patients with depression. The JAMA Psychiatry article noted that seven studies involving 147 patients have provided evidence of ketamine hydrochloride’s ability to produce “rapid and robust antidepressant effects” in patients with mood and anxiety disorders that were previously resistant to treatment. However, a much larger sample size is typically required before a drug is approved by the FDA, Nemeroff said.

“Current antidepressants and other evidence-based psychiatric treatments are not successful for many patients,” Nemeroff said. “Because depression is associated with suicide — one of the nation’s top ten causes of death — there is a pressing need to find effective new treatments. But it is not yet clear whether ketamine is safe or effective in short- or long-term treatment.”

Large-scale studies are needed to determine if ketamine is safe and effective for appropriate patients, Nemeroff added.

“The fact that ketamine is a commonly abused substance in the United States and abroad should also be taken into consideration in exploring its role as a potential treatment for a common psychiatric disorder,” he said.

Tags: antidepressant, anxiety, depression, FDA, JAMA, ketamine, prescription, psychiatry, research, substance abuse