Godfrey’s search for relief pointed her towards ketamine. Low, intravenous doses have been found to boost mood and curb suicidal thoughts, but the FDA has never approved ketamine as a treatment for depression. And the American Psychiatric Association (APA) warns patients about the potential for abuse and the lack of large, long-term studies of its effectiveness.
Even so, ketamine clinics like the one treating Godfrey have sprung up across the United States.
“The lack of information [on ketamine] is really quite dramatic when you look at the proliferation of use in certain communities,” said former APA President Dr. Alan Schatzberg. He helped write an APA statement about ketamine urging caution.
A new, safer alternative?
Spravato, the drug approved Tuesday, is touted as a much safer cousin of ketamine.
Speaking this week with National Public Radio, Courtney Billington, president of Janssen Neuroscience, said that, unlike ketamine, “the amount of active ingredient that’s in this product is at a very, very low dose.”
In four studies that led to its approval, Spravato performed well against placebo, the FDA said, showing a “statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days.” That’s a much faster time to symptom relief than many antidepressants.
One longer-term trial suggests that Spravato’s benefit lasts, the FDA said.
Side effects can occur, however.
“The most common side effects experienced by patients treated with Spravato in the clinical trials were dissociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk,” the agency said.
Because of these potential effects, people with high blood pressure or certain vascular disorders should not take Spravato, and people should get a night of “restful sleep” before attempting to drive after taking the drug.
How do medicines like Spravato and ketamine help ease depression?
It’s not clear, Schatzberg said. One common theory is that they affec the brain’s response to the neurotransmitter glutamate. Neurotransmitters are chemicals that send signals from one part of the brain to another and from the brain to the body. Essentially, the thinking goes, these meds rewire the brain.