The Food and Drug Administration has approved a new medication that could improve accessibility of treatment for millions of people with treatment-resistant depression, and clinical trials show it can reduce symptoms within hours.
The drug, Spravato, contains esketamine, a chemical related to ketamine, a human anesthetic and veterinary sedative with a reputation for abuse as a party drug. Scientists have studied the potential for ketamine to treat severe depression for years, and psychiatrists have even prescribed it off-label, but this is the first time the FDA has indicated its use as an antidepressant.
The treatment will be available to patients with major depressive disorder who haven't responded to at least two antidepressants and to those with severe depression who are in imminent danger of suicide.
Due to its side effects, including sedation and dissociation, administering Spravato is much more complicated than prescribing a daily pill. In conjunction with beginning an oral antidepressant, patients will be required to go to a clinic twice a week for the first four weeks, where they will learn how to administer the nasal spray under the supervision of a medical professional. Treatment continues once a week for the next four weeks, and then weekly or biweekly after that. Under FDA guidelines, patients must be monitored by medical professionals for at least two hours after receiving a dose until they are approved to leave. The FDA also warns that patients should not drive or operate machinery until the next day, after a restful sleep.
Dr. George Sanacora, a psychiatrist, professor, and director of the Yale Depression Research Program, recognizes that these intense requirements will lower the percentage of people struggling with treatment-resistant depression who are able to access this treatment. However, he notes that Spravato actually requires a much lower time commitment than other existing options for treatment-resistant depression, including electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS).
Sanacora also anticipates Spravato, like ECT, will be covered by most insurance companies, whereas coverage of TMS is more difficult to obtain because it requires strong documentation of non-response to previous treatments.
"[Esketamine] is the first truly novel antidepressant in decades, which offers great hope to people," Sanacora says. "However, this isn't another Prozac. This really is a very different type of medication and it needs to be used responsibly. People shouldn't get the idea that it's the first thing they should go for."