A recent trial testing slow-release oral ketamine pills as a treatment for treatment-resistant depression has shown promising results in terms of safety but has raised concerns about efficacy. The trial, sponsored by Douglas Pharmaceuticals, found that the ketamine pills were safe compared to a placebo and showed some effectiveness in treating depression in patients who had not responded to previous antidepressants.
However, the trial also revealed that a significant number of participants dropped out before completion due to a lack of efficacy, indicating that the pool of patients who may benefit from this treatment could be limited. The trial used an “enrichment” design, where participants who initially responded to ketamine were selected to continue in the trial, but even among these enriched participants, many still did not experience significant improvements in their symptoms.
The trial consisted of two phases – an initial enrichment phase where all participants were given ketamine, followed by a randomized, double-blind, placebo-controlled phase where participants were given different doses of ketamine twice weekly for 12 weeks. The results showed that the 180-mg dose of ketamine had statistically significant improvements in depressive symptoms compared to a placebo, but a significant number of participants dropped out of the trial before completion.
It is important to note that the trial design may have overestimated the actual population levels of treatment response, and future trials are needed to address this issue. The researchers reported that the oral doses of ketamine appeared to be safe, with no significant cardiovascular side effects noted. Common side effects included headaches, dizziness, anxiety, and depressed mood, but rates of dissociation and sedation were low.
The study did not collect specific data on the potential for abuse or diversion of ketamine, but researchers reported anecdotally that participants did not show signs of craving the pills. Concerns may arise among clinicians about the dosing of ketamine at home, as one participant was removed from the trial due to non-compliance.
Overall, while the trial showed some promising results in terms of safety and efficacy of slow-release oral ketamine pills for treatment-resistant depression, further research is needed to determine the full extent of its benefits and limitations. The findings highlight the complexity of treating depression and the importance of continued research into novel therapies for this challenging condition.
