A new ketamine-based antidepressant raises hope — and questions


depression drug
FAST RELIEF A new drug based on the anesthetic ketamine relieves depression in hard-to-treat cases, but its long-term consequences are unknown.

With great fanfare, a new antidepressant entered the U.S. market in March, the first fundamentally new medicine for depression in decades. Based on the anesthetic ketamine, the drug — called Spravato — is intended to help people with severe depression quickly, taking effect within hours or days instead of the weeks that typical antidepressants take. But for all the hubbub, big questions have gone unanswered about the drug, developed by Janssen Pharmaceuticals, Inc.

Some psychiatrists are concerned that the drug was approved by the U.S. Food and Drug Administration based on skimpy data, under standards that were less rigorous than those required for previous antidepressants. It remains unclear, for example, what happens as someone stops taking the drug, as well as whether it has long-term effects.

The data on Spravato raise more questions than they answer, says psychiatrist Alan Schatzberg of Stanford University. “And I think that’s unfortunate.”

Despite those unknowns, some psychiatrists are relieved to have another drug to try, particularly for people with depression so severe that other drugs have failed to help. Spravato “does something that very few things in psychiatry can do — it works for people who didn’t respond to other treatments, and it works fast,” says psychiatrist Dan Iosifescu of New York University’s School of Medicine. “I really welcome having another powerful tool in my toolbox.”

Old drug, new use

Ketamine, an FDA-approved anesthetic that has been in use for decades, comprises two mirror image molecules: esketamine and arketamine. Spravato, a nasal spray, is made of just esketamine (SN: 3/30/19, p. 13). And like ketamine, which is abused in part for the floating sensation it produces, esketamine may be used illicitly. That has prompted the FDA to put tight controls over the new drug, which can cause hallucinations, sedation and dizziness.

In the weeks since the FDA’s approval of Spravato, receptionists at the clinics of Gerard Sanacora, a translational neuroscientist at Yale School of Medicine, are answering “dozens of phone calls every day” from patients and their loved ones eager for esketamine’s promise of quick relief. But “this is not a medicine for everybody,” says Sanacora, who has consulted for Janssen. Spravato, which is intended to be used with another antidepressant, was approved for use only in people who have not gotten relief from at least two other treatments. An estimated 5 million people in the United States live with this type of severe depression.

But because the drug is liable to be abused, and due to its potential side effects, Spravato can be taken only in a clinic, where patients will be monitored for several hours after their dose — “This is not a take-at-home medicine,” Sanacora says.

Those rules were set also because Spravato has largely been tested in people with severe depression, and results of its effectiveness have been mixed. So far, three one-month clinical trials have been conducted in which patients were randomly assigned to receive either the drug or a placebo, and neither patients nor doctors knew who belonged to which group. In two of the three trials, participants didn’t get any better on the drug than they did on the placebo.

In the third monthlong trial, which included 224 people, participants had their depression symptoms improve after a four-week stint of taking Spravato twice a week….

Marcela
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Marcela

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