Read Original Release

Ketamine for depression? 16-person study, described as ‘promising,’ should have been treated more carefully

World-first ketamine trial shows promise for geriatric depression

Our Review Summary

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. 

 

Why This Matters

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.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.”

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

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.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the news release commit disease-mongering?

Satisfactory

No mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Funding sources and presence or absence of conflicts of interest are not mentioned.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the news release establish the true novelty of the approach?

Satisfactory

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.

Total Score: 4 of 10 Satisfactory

Comments

We Welcome Comments. But please note: We will delete comments left by anyone who doesn’t leave an actual first and last name and an actual email address.

We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.