Approved, but Not for Depression
Dr. Feifel: Though approved decades ago by the US Food and Drug Administration (FDA) for human use as an anesthetic, ketamine it is not FDA approved for depression, and I don't think it's likely ever to be approved for depression because the patent on ketamine has long expired.
Medscape: How might this affect its clinical use in this area?
Dr. Feifel: Typically, when we are presented with promising therapeutic data on a compound, it is a novel investigational agent that hasn't yet been approved by the FDA for any human use and is thus not in the hands of the medical community at large. As a potential "new" medication for depression, ketamine is unique because it is already approved for human use and has been used in humans for a long time with a very good safety record. This affords the opportunity of using it off-label in a clinical context for depression while the research into that indication continues on a parallel track.
Medscape: In your opinion, is there enough evidence to support using ketamine off-label for depression?
Dr. Feifel: There are many people with clinical depression who are in extreme distress right now. They have virtually no quality of life and are struggling to stay alive every day. They are often without hope because they have tried just about every conventional antidepressant treatment. For many of these people, ketamine may provide some relief of their depression. Therefore, as long as such a patient understands the limitations of ketamine, I don't see any reason to deny him or her the opportunity to benefit from this potential game-changing drug.
I selectively offer ketamine to appropriate patients in the context of full disclosure. At UCSD, we have developed a consent form that lets the patients know that ketamine is not FDA approved for depression, that it is still undergoing study for its antidepressant effect, that it may or may not effectively alleviate their depression, and that if it does, the benefits from a single administration will be transient. The consent form also makes it clear to the patient that this treatment is generally not covered by insurance, so there will be out-of-pocket costs. We let them know all of this upfront so there is no illusion of what we are offering. Most patients that I encounter already know these issues because they have extensively researched the use of ketamine for depression and have specifically sought out this treatment.
Desperate for Relief
Medscape: Are you finding that your depressed patients are satisfied with the results they're seeing from ketamine?
Dr. Feifel: Yes and no. The majority of patients, but not all, are very pleased with the acute effects of their ketamine treatments. The problem lies in the fact that nobody yet knows how to most effectively translate the acute benefits of ketamine into long-term benefits. Aside from a lack of response, the lack of sustainability is where patients may become disappointed.
Medscape: How widely is ketamine used around the country for psychiatric purposes?
Dr. Feifel: Since we first started offering ketamine for depression, we have seen a few other clinicians in both academic and private practice settings starting to offer it. Ketamine is slowly becoming clinically available.
Medscape: Do you reserve ketamine for the most treatment-refractory patients?
Dr. Feifel: At this point, the cost-benefit ratio justifies using ketamine, in my opinion, in highly treatment-refractory patients, a population which, unfortunately, is plentiful. It is disheartening how many patients with depression actually fall into a category where none of the current treatments give them significant relief.
Maybe in the future, as our experience and comfort with using ketamine in this population increase, it will justify gradually extending it to patients who are earlier in the process of finding a treatment that works for their depression.
UCSD © 2013 University of California, San Diego, School of Medicine
Cite this: Hope in Treatment-Refractory Depression - Medscape - Jan 10, 2013.