A nasal spray version of esketamine was more effective against treatment-resistant depression than more commonly used drugs, a study published Wednesday found. New England Medical Journal found.
Esketamine is a stronger form of ketamine, an anesthetic that doctors have used for years to treat depression. Janssen Pharmaceuticals’ nasal spray is sold under his Spravato name. approved Janssen funded new research conducted in 24 countries in Africa, Asia, Europe and South America.
“Treatment-resistant depression is a pretty serious problem,” says Dr. Michael Gruenebaum, associate professor of psychiatry at Columbia University Medical Center in New York City and research psychiatrist at the New York State Psychiatric Institute.
The condition (generally defined as depression that does not respond to two or more consecutive medications) is estimated to affect 30% to 50% of patients with major depressive disorder, according to a new study. said Gruenebaum, who was not involved in the study but has studied ketamine.
In this study, 336 adults with treatment-resistant depression received either selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) in addition to the antidepressants they were already taking. They were randomly assigned to receive nasal esketamine. In addition, he had 340 patients add quetiapine to their medication regimens. Quetiapine is the generic name for the antipsychotic drug Seroquel, which has been on the market since 2007 and is sometimes used to increase the effectiveness of antidepressants in patients with treatment-resistant depression.
At eight weeks, 27.1% of patients taking esketamine were in remission, or virtually symptom-free, compared with 17.6% of those in the quetiapine group. After reaching remission at 8 weeks, 21.7% of patients in the esketamine group remained in remission by week 32, compared with 14.1% of patients taking quetiapine.
Gruenebaum said the results were “very significant.”
Dr Alan Young, one of the study’s authors and an academic psychiatrist at King’s College London, said that while 27.1% may seem small, it was better than the benchmark. US research on depressionA study conducted earlier this century showed that 13% of patients with treatment-resistant depression achieved remission in response to the drugs available at the time, Young said.
And remissions in early studies didn’t last long, Young added. “They got better, but it was temporary. They went back to being depressed again,” he said.
Still, the remission rates seen in the esketamine studies were low, said Dr. Amit Anand, professor of psychiatry at Harvard Medical School and director of translational clinical trials at Brigham and Women’s Hospital in Boston.
“The bottom line is we need to develop better treatments,” said Anand, who studies ketamine but was not involved in the new paper.
It’s not surprising that not all patients who achieve remission at week 8 remain in remission by week 32, Gruenebaum said. “I wasn’t shocked that it looked fundamentally different than standard antidepressants,” he said.
The study also showed that a number of patients in both groups continued to reach remission beyond eight weeks. At week 32, 49.1% of patients in the esketamine group and 32.9% of patients in the quetiapine group were in remission.
This study had limitations. It compared nasal esketamine to only one other drug. Other drugs used to enhance treatment for patients with treatment-resistant depression include low-dose lithium, thyroid medications, atypical antidepressants such as bupropion, and pramipexole, a drug used to treat Parkinson’s disease. .
Additionally, Grunebaum noted that 90% of patients are white, so the results may not apply to other races.
Anand said the method of drug administration may have confounded the results. Those receiving esketamine nasal spray had to come to the hospital twice a week to take the nasal spray in the presence of a health care worker, while those receiving quetiapine took the tablets at home. I had to.
“There’s no comparison in terms of the amount of care they give to patients,” he says. “That’s huge.” The extra attention given to patients in the esketamine group may have itself reduced their feelings of depression.
The long-term safety of esketamine is unknown. Studies in people addicted to ketamine show it can damage brain tissue and the lining of the bladder, Gruenebaum said. He does not prescribe ketamine in any form to his patients.
“Usually you can find a standard combination of drugs that works well,” he said. “We are awaiting further information on long-term safety.”
Although Sprabat may be covered by insurance such as Medicare, doctors must spend a lot of time documenting treatment-resistant depression, Gruenebaum said. Other drugs used to enhance treatment are also more easily covered by insurance, and many are available as generic drugs.
Additionally, ketamine is considered a controlled substance in the United States due to its potential for abuse and addiction. Patients must take it at their health care provider’s office or clinic. Many people may prefer medications that can be taken at home.
However, study author Young said the number of visits for the nasal spray was initially twice a week, with maintenance doses decreasing over time to every two weeks. “I have one patient who takes it once every eight weeks, and he’ll probably be able to stop it soon,” he says.
