New research supports the efficacy and safety of esketamine nasal sprays in the treatment of depression in people who have not responded to prior treatment. The research will be published online today in the American Journal of Psychiatry . This study is one of the key studies leading to the recent approval of the esketamine nasal spray approved by the FDA, along with an oral antidepressant for use in patients with treatment-stable depression.
Depression is common and as many as one third of people with depression are considered resistant to treatment ̵
Michael Thase, M.D., one of the study authors, described the study during a briefing held at the American Psychiatric Association's annual meeting. Phase 3, double-blind, actively controlled study was conducted in 39 outpatient centers from August 2015 to June 2017 and involved nearly 200 adults with moderate to severe depression and a history of not responding to at least two antidepressants. Participants were randomly assigned to one of two groups. One group was switched from their current treatment to esketamine nasal spray (56 or 84 mg twice a week) plus a newly initiated antidepressant (duloxetine, escitalopram, sertraline or prolonged venlafaxine). The other group was switched from their current treatment to a placebo nasal spray in combination with a new antidepressant.
The improvement in depression among those in the esketamine group was significantly greater than the placebo group on day 28. Similar improvements were seen in past time points.
Side effects in the esketam group generally occurred shortly after taking the drug and resolved 1.5 hours later while the patients were in the clinic. The most common side effects included dissociation, nausea, dizziness, dysgeusia (distortion of taste) and dizziness. Seven percent of the patients in the esketamine group discontinued the study due to side effects.
"This study of esketamine was one of the pivotal trials in the FDA review of this treatment for patients with treatment-resistant depression. Not only was adjuvant esketamine treatment effective, the improvement was evident within the first 24 hours," said thase. "The new mechanism of action of esketamine combined with the rapid benefit justifies how important this development is to patients with difficult to treat depression."
In an accompanying commentary in American Journal of Psychiatry ] Alan Schatzberg, MD, at Stanford University School of Medicine, highlights several areas where information on the best use of esketamine is lacking, such as how long and how often it should be prescribed and raises concerns about the possibility of abuse. While noting that esketamine may be useful for many patients with depression, he warns that "there are more questions than answers with intranasal esketamine, and caution should be exercised in its use in clinical practice."
The comment describes esketamine's relationship to ketamine, an anesthetic in use for decades, which has also been used recreationally as a party drug. While ketamine is administered intravenously at subanesthetic doses, an effective treatment is used for refractory depression, intravenous ketamine for the treatment of depression is currently not approved by the FDA, although it may be prescribed off-label. Ketamine is composed of molecules that are mirror images of each other (S-ketamine and R-ketamine). It is the intranasal formulation of the S-ketamine molecule (ie, esketamine) that received FDA approval.
FDA panel backs ketamine-like drug for depression
American Journal of Psychiatry (2019). DOI: 10.1176 / appi.ajp.2019.19020172
Study supports the effectiveness of new fast-acting antidepressants, esketamine nasal spray (2019, May 21)
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