Depression is the leading cause of disability worldwide, affecting more than 300 million people of all ages around the world. The most commonly used antidepressant medications are called selective serotonin reuptake inhibitors (SSRIs). Only about one third of people with major depressive disorder achieve remission after treatment with SSRIs. When the first medication doesn’t work, the next steps are usually to switch to or add another SSRI medication. After trying different options or combinations, almost 70% of people with depression will be able to achieve remission. Unfortunately, the remaining 30% of people will not be able to find a treatment that works, and are said to have treatment resistant depression.
Ketamine was first approved for use as an anesthetic in 1970 and was later abused as a party drug, thereby creating a stigma surrounding its use in a medical setting. After a series of studies in the early 2000s, scientists began investigating ketamine for its rapid-acting antidepressant effects. Subsequent studies showed promising results and, last week, the FDA approved the use of the nasal spray Spravato, the first ketamine-based antidepressant for patients who haven’t responded to two or more SSRI antidepressants. Unlike SSRIs, which can take weeks or months to begin taking effect, a single dose of ketamine was found to produce antidepressant effects within a few hours and lasted at least one week after the single treatment. To avoid recreational use of the medication, the FDA has only made the drug available through a restricted distribution system. The drug will be administered under supervision of healthcare professionals and patients will be monitored for two hours after treatment for potential side effects.
In a space that has been limited to the use of SSRIs, this opens up many new opportunities for the treatment for depression. At the same time, safety and caution are very important. Typically, antidepressants are approved on the basis of two positive short-term trials. However, since the benefits outweighed the associated risks, the FDA advisory committee voted to approve the drug after only one positive trial. Additional, larger clinical trials are needed to assess long term safety and efficacy of ketamine-based antidepressants. It will also be important to maintain perspective throughout the hype around ketamine in the media. In the excitement, patients have begun to think of ketamine as a miracle drug, requesting it before standard SSRI treatments. Whether ketamine-based antidepressants are more effective than SSRIs, for safe and successful treatment of depression, remains to be investigated.
Managing Correspondent: Jeremy Gungabeesoon
News Article: A Ketamine-Based Nasal Spray For Depression Has Just Been Approved by The FDA. ScienceAlert
Original Article: FDA approves new nasal spray medication for treatment-resistant depression. FDA News Release
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