Ketamine telehealth company Mindbloom has released the findings of what it claims to be the largest study yet of at-home ketamine treatment for depression. The paper, published in The Journal of Affective Disorders, surveyed 11,441 Mindbloom patients experiencing moderate to severe depression or anxiety. Each patient received four doses of oral ketamine at home over four weeks, with support from Mindbloom, including group integration sessions and 1:1 coaching. The data was collected using questionnaires.
In the paper’s declaration of competing interests, only two of the four authors were not involved with Mindbloom. One received minor consulting fees from the company, and the other was an employee of Mindbloom. The study was also limited by not having a placebo or control group, which means that it did not meet the standards of a randomized control trial. Further, the study did not meaningfully explore the potential for ketamine abuse and addiction—concerns that experts have been voicing as the at-home ketamine therapy industry continues to expand. Studies in humans show that regular ketamine use is associated with symptoms of addiction.
Despite these limitations and potential conflicts, the study still contained some interesting results. Overall, it found that 62 percent of participants reported clinically-significant improvements. As has been the case with other studies, people with moderate depression were more responsive to the treatment compared to those with severe depression. Younger people had the greatest probability of improvement. The paper’s authors cite prior studies showing that younger age is associated with more positive expectations of psychedelics and more intense psychedelic effects.
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Around 5 percent of participants reported adverse effects. 12 patients discontinued their treatments due to intense dissociation and other overwhelming experiences. Two patients experienced flashbacks and re-experienced prior trauma after administering their ketamine treatments, and two other patients had to go to the Emergency Department after experiencing a “depressed level of consciousness.” The FDA released a warning last year that ketamine products, including oral ketamine, can be dangerous due to risks of sedation, dissociation, worsening of psychiatric disorders, abuse and misuse, increases in blood pressure, respiratory depression, and lower urinary tract and bladder symptoms.
Some experts in the industry have argued that a formal Risk Evaluation Mitigation Strategy (REMS) should be established to regulate the ketamine therapy industry, because of concerns of abuse, excessive dissociation, sedation, and other risks. The authors of the paper argued against the need for such a protocol, when administered with the kinds of clear instructions and degree of supervision involved in the study.
“Rather than providing significant clinical benefit, such programs are likely to increase administrative burden on healthcare systems, while decreasing access to treatment,” the paper’s authors wrote. They also argued that telehealth could be used to decrease the cost of psychedelic therapy.
