Psilocybin on the threshold of the clinic

Treatment of depression with psilocybin enters the final phase of research

Svetlana Maslova, Hi-tech+

By the end of the year, the 3rd phase of clinical trials of psilocybin therapy for depression will be launched with the participation of approximately 1,000 patients with resistant depression. The results should become an evidence base for the official approval of such a treatment method. Currently, a lot of data on the effectiveness of psilocybin treatment is already available, but there are not enough results of long-term placebo-controlled studies for regulatory authorities. If successful, patients who have not been helped by antidepressants and psychotherapy will begin to receive a prescription for psilocybin.

The vast majority of clinical studies on psilocybin in the treatment of depression remain in the early stages, which does not accelerate the availability of promising therapy in any way. Now scientists from Compass Pathways have announced the launch of the third final phase of research involving about 1,000 patients with resistant depression by the end of this year.

Last year, they completed the second phase, which demonstrated clinically significant improvement in volunteers with a single dose of psilocybin at a dosage of 25 mg. In the final phase, it is necessary to confirm the efficacy and safety of 25 mg in a single and double dosage. A second dose will be offered to patients after three weeks if there is no initial response. In addition, additionally, scientists will re-evaluate the potential of 10 mg and 1 mg.

Compass Pathways plans to get permission for its therapy from the US FDA regulator by the end of 2025.

Currently, patients with resistant depression who have not been helped by antidepressants and psychotherapy do not have any treatment options left. The approval of psilocybil for use in clinical practice will be able to offer a quick and effective tool for treatment, the authors are sure.

Portal "Eternal youth" http://vechnayamolodost.ru