The treatment-resistant major depression is closer to having a new therapeutic alternative: long acting ketamine. This is revealed by a study published in the journal Nature Medicinewhich considers it an “effective, safe and well tolerated” option for this type of patient.
In this phase 2 trial, researchers found that a 180 mg dose of R-107 – a type of long-acting ketamine tablet – given twice a week showed a significant improvement in depressive symptoms compared to placebo, with a mean difference in MADRS score of -6.1 points. Furthermore, the relapse rate was significantly lower in the 180 mg group (42.9%) compared to placebo (70.6%).
The study, titled Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial, was carried out between May 2019 and August 2021, involving 231 adult patients with treatment-resistant major depression. The research was designed in two phases: in the first, patients received a daily dose of 120 mg of R-107 for five days. Those who responded to the treatment (72.7%) were selected for the second, double-blind trial, where they were randomized to receive different doses of R-107 or a placebo for 12 weeks.
One of the most notable findings of the study was the “excellent tolerability” of the extended-release formulation of ketamine. Unlike other forms of ketamine administration, such as intravenous or intranasal, which are often associated with significant side effects such as sedation and dissociation, R-107 tablets had minimal reports of these symptoms. The most common side effects “were headache, dizziness and anxiety”, of mild or moderate intensity in most cases.
In addition to efficacy and safety, the study also explored several secondary outcomes, such as remission and response rates at different time points. Although these were greater in the active treatment groups compared to placebo, not all of these differences were statistically significant. However, the overall results support the hypothesis that an extended-release formulation of ketamine may offer sustained benefits in reducing symptoms of depression.
Limitations of Ketamine Use
Despite the promising results, the study also has a series of limitations to take into account. One of them has to do with the enrichment design used, which excludes non-responders before the double-blind treatment phase, could overestimate response to treatment in the general population. Furthermore, although data on oral administration of ketamine are promising, they are limited compared to other routes of administration.
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