This news release does a marginal job of describing what appears to be the first randomized, placebo controlled trial of the anesthetic agent ketamine for hard-to-treat depression in older adults. It offers a baffling, apparently incorrect account of the study findings and skimps on explaining what the alternatives are for treating depression in older adults. It could also have been greatly strengthened by noting the limitations of the study. Only 16 volunteers were enrolled and the study had only a 5-week controlled treatment period with a 6-month uncontrolled follow-up.
The release earns praise for its explanation of the complex protocol of the research, the limitations of previous studies in determining the value of ketamine and noting that there is still much to learn about the drug and its long-term effects and risks.
In the end, though, this release doesn’t leave us any more clued in about how ready for prime time clinical use ketamine is — or is not. And its headline is a good reminder of why “promising” is one of the 7 words you shouldn’t use in medical news.
Ketamine is an old, relatively inexpensive, fast acting anesthetic drug when used in common doses, inducing a trance-like state, sedation, and temporary “amnesia.” It’s in the same class of drugs as nitrous oxide and propofol, the latter often used at the start of surgical anesthesia. If a safe, effective way can be developed to extend the drug’s use to help treatment-resistant older people with serious depression, that would be a significant advance in improving the quality of life for millions.
The release didn’t mention the cost of ketamine infusion therapy. Another way to address costs in the release would have been to include a discussion of the medical and social costs of depression.
The release’s presentation of study outcomes is baffling. The published paper describes a 5-week randomized controlled trial followed by a longer 6-month follow-up phase that was open label (meaning patients and doctors knew who was getting ketamine). The RCT period provides the strongest evidence, but the news release seems to offer only the 6-month open label results when it says,
“By the six-month follow up, 43 percent of participants (7 of 14) who completed the RCT had remitted, with five remitting at amounts below the commonly-used dose of 0.5 mg/kg. Repeated treatments also resulted in a higher likelihood of remission or a longer time to relapse, with an overall response and remission rate of 68.8 percent for the patients receiving ketamine treatment.”
First of all, according to the published paper, the outcomes described in the news release — “7 out of 14” remitters and “68.8% overall response and remission rate” — are from the initial 5-week RCT. The news release, however, describes them as being from the 6-month open label follow-up. That’s simply incorrect. Second, 7 out of 14 is exactly 50 percent but is described as being “43 percent” in the news release. This 43 percent figure does not not seem to appear anywhere in the published study and we’re not sure what it represents.
Lastly, the release lacks specifics that would help readers understand the magnitude of benefit. What is an “overall response and remission rate”? How much better does one have to be to be considered a “responder” or “in remission.”
Although the release doesn’t say how widespread side effects were in the study population, it does mention some of the side effects and it’s clear to readers that ketamine is not a trouble-free drug.
Although the release could have used more details about the patient population, including the diagnostic criteria used to assess their depression status and previous therapies, it does a good job of explaining the results of a complicated “cross over” study design and underscoring the importance of the tailored dosing used on the patients.
However, the limitations of the research needed to be spelled out but weren’t. It enrolled only 16 volunteers and lasted one 5 weeks — hardly long enough to generate recommendations for the broader population of elderly individuals with depression.
No mongering here.
Funding sources and presence or absence of conflicts of interest are not mentioned.
This is the one area where more information was greatly needed. The release notes that ketamine therapy is intended for treatment-resistant patients, but we learn nothing about about the effectiveness of other therapies, like anti-depressants, electroconvulsive therapy (ECT), cognitive behavioral therapy, etc.
The release doesn’t address the availability of ketamine for depression head-on. We’re not sure what regulatory issues may apply in Australia, where the release was issued from, but since the information is being distributed to a worldwide audience via a news wire, some comment on this issue would have been appropriate and helpful. The implication is that ketamine is not yet in general clinical use for treatment geriatric depression. But in the U.S., at least, clinics are starting to pop up around the country that offer this therapy. Are these treatment centers reputable? Readers aren’t given any guidance.
The release does a good job of explaining what is new about the study and the research team’s particular way of carefully tailoring ketamine doses to each patient.
The release doesn’t employ unjustifiable language.