The potential for using psilocybin to treat patients with major depressive disorder
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Reviewed by Dat Tien Nguyen, B.A, ScM.
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Posted on November 11th, 2022
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Previous study had reported that the usage of psilocybin in treating cancer also elicits an antidepressant effect. The compound can be isolated from several species of mushroom, and consumption for recreational purposes can result in euphoria and hallucination. Due to its ability to induce an euphoric sensation, psilocybin can potentially be used to treat patients with major depressive disorder. A recent phase 2 clinical trial had reported on the effect of single-dose psilocybin therapy in treating patients with major depressive disorder that had not been responsive to other treatment.
The multi-center study includes 233 patients above the age of 18 that have been treated for major depressive disorder in an outpatient setting but have not been responsive to previous treatment. Besides standard supportive care, the patients were randomly assigned to receive 3 different dosages of psilocybin: 25-mg, 10-mg, and 1-mg. They were instructed to take 1 dose of the assigned concentration and they were followed up for 12 weeks. The Montgomery–Åsberg Depression Rating Scale (MADRS) - with the minimum severity of 0 and a maximum severity of 60 - was used to assess the severity of depression. By the third week of observation, those who have received 25-mg of psilocybin experience an average 12 points drop in MADRS score which is significantly higher than those who have received the lower dosages. 37% of those who have received 25-mg of psilocybin experience a 50% percent drop in MADRS score (the 19% and 18% of the 10-mg and 1-mg group experience the same clinical benefit respectively). By the end of surveillance at week 12, this clinical effect is sustained in 20% of the patients, significantly higher than the lower dosages. In terms of safety, 24% of the patients reported headache, 22% reported nausea and the frequency of dizziness and fatigue is 6% each. These results are promising, but this study has a few limitations. First, the psilocybin used in this study was a proprietary formulation. In order to proceed to later stage clinical trials, the exact composition of the treatment will need to be revealed. Second, the trial lacks ethnic diversity; thus, this preliminary finding cannot be generalized for the entire population. Last, future studies should compare the efficacy and safety of the proprietary formulation of psilocybin with the current pharmaceutical therapy.
The multi-center study includes 233 patients above the age of 18 that have been treated for major depressive disorder in an outpatient setting but have not been responsive to previous treatment. Besides standard supportive care, the patients were randomly assigned to receive 3 different dosages of psilocybin: 25-mg, 10-mg, and 1-mg. They were instructed to take 1 dose of the assigned concentration and they were followed up for 12 weeks. The Montgomery–Åsberg Depression Rating Scale (MADRS) - with the minimum severity of 0 and a maximum severity of 60 - was used to assess the severity of depression. By the third week of observation, those who have received 25-mg of psilocybin experience an average 12 points drop in MADRS score which is significantly higher than those who have received the lower dosages. 37% of those who have received 25-mg of psilocybin experience a 50% percent drop in MADRS score (the 19% and 18% of the 10-mg and 1-mg group experience the same clinical benefit respectively). By the end of surveillance at week 12, this clinical effect is sustained in 20% of the patients, significantly higher than the lower dosages. In terms of safety, 24% of the patients reported headache, 22% reported nausea and the frequency of dizziness and fatigue is 6% each. These results are promising, but this study has a few limitations. First, the psilocybin used in this study was a proprietary formulation. In order to proceed to later stage clinical trials, the exact composition of the treatment will need to be revealed. Second, the trial lacks ethnic diversity; thus, this preliminary finding cannot be generalized for the entire population. Last, future studies should compare the efficacy and safety of the proprietary formulation of psilocybin with the current pharmaceutical therapy.