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BY M. ALEXANDER OTTO

REPORTING FROM APA 2019

SAN FRANCISCO – Serial ketamine infusions eliminated suicidal ideation in more than two-thirds of patients at a psychiatry office in Connecticut but at significantly higher doses than those recently approved for Janssen’s new esketamine nasal spray (Spravato). The patients were treated by Lori V. Calabrese, MD, at Innovative Psychiatry, her private outpatient practice in South Windsor. She presented her first 235 IV ketamine cases at the American Psychiatric Association annual meeting. It was likely the largest real-world series to date of ketamine infusions for treatment-resistant depression and suicidality.

The patients, 14-84 years old but mostly middle aged, received six infusions over 2-3 weeks, starting at 0.5 mg/kg over 40-50 minutes, then titrated upward for dissociative effect to a maximum of 1.7 mg/kg. Subjects filled out the nine-item Patient Health Questionnaire (PHQ-9) at baseline and before each in- fusion. Item nine – “thoughts that you would be better off dead or of hurting yourself in some way” – was used to gauge suicidality. That item has been validated as a predictor of suicide risk.

Among 144 patients (62%) who were markedly suicidal, ketamine infusions were tied to diminished ideation in 118 (82%) and eliminated ideation in 98 (68%). They were severely depressed at baseline; PHQ-9 scores fell in 127 (89%), and depression went into remission in 89 (62%). There were no suicide attempts, ED visits, or hospitalizations during treatment and at 4-week follow-up.

“Even if they had been suicidal for a long time, been hospitalized, and made suicide attempts, 68% had full remission of suicidality. This is a life-saving treatment, a breakthrough option for psychiatrists,” Dr. Calabrese said.

Lori Calabrese MD

The results are “fabulous,” said Jaskaran Singh, MD, who said he was clinical leader of the esketamine program at Janssen. “You prevented hospitalizations and saved lives,” Dr. Singh said. “This is a marvelous study that we should have done.”

Dr. Calabrese’s report, however, raises the question of whether the nasal spray will be potent enough to achieve the same results. She found that cessation of suicidal thoughts required an average dose of 0.75 mg/kg IV ketamine, which is higher than the 0.5 mg/kg used by many ketamine infusion programs in the United States. It’s also significantly higher than Spravato dosing. The spray was cleared by the Food and Drug Administration in March for use with an oral antidepressant for treatment-resistant depression.

Esketamine is approved in doses of 56 mg, which works out to almost 0.2 mg/ kg, and 84 mg, which works out to less than 0.4 mg/kg. Dosing is twice weekly at first, then weekly or biweekly for maintenance. When asked whether he thought those doses would be enough to prevent suicide, Dr. Singh said his company has finished two trials in suicidal patients and would present results later in 2019.

Dr. Singh

Dr. Calabrese, meanwhile, plans to incorporate intranasal esketamine into her practice, but will continue to offer ketamine infusions. “How can I not? I’ve seen how effective they are,” she said.
Insurance companies have sometimes covered them for patients with a history of psychiatric ED visits and hospitalizations, on the grounds that infusions will prevent future admissions. But patients have to fight for coverage – and feel well enough to do so.

That’s the main reason Dr. Calabrese plans to start offering Spravato; coverage will likely be less of a hassle for patients once Janssen works out the insurance issues. Spravato has been reported to cost about $600-$900 per treatment session.

Posted with permission from the July 2019 issue of Clinical Psychiatry News ® Copyright © 2019 IMNG/Frontline Communications Medical Group LLC. All rights reserved.

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