Researchers are conducting clinical trials for the effects of psilocybin -- a hallucinogen found in ‘magic mushrooms to see its effects on individuals experiencing acute depression. This is the largest clinical trial of its kind to date.
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Reported first by STAT. the trial was conducted by the pharmaceutical company Compass Pathways and involved 233 participants from 10 countries in North America and Europe. The participants were split into three groups, where each received a different dose of psilocybin along with psychological support. Before the trials began, all the participants were off antidepressants.
79 patients received a one-time 25-milligram dose of the drug, 75 received a 10-milligram dose and 79 received a 1-milligram dose. The lowest dose functioned as a placebo. The trial was double-blinded with both organisers and participants knowing which treatment dose was given to which patient.?
Trial organisers made use of the Montgomery-Asberg Depression Rating Scale -- a common measure of clinical depression -- to determine the symptoms of the participant before treatment and then three weeks afterwards.?
As the third week rolled in, the ratings of people in the 25-milligram dose group had dropped 6.6 more points on average compared to the ratings of individuals in the low-dose group. However, they also saw that participants in the 10-milligram group didn’t report results drastically different from the low-dose group.?
Overall, 29.1 percent of the patients in the 25-milligram dose group had entered remission by the third week, compared to just 7.6 percent from the placebo group. Three months after the treatment, 24.1 percent of the 25-milligram dose group showed a sustained response indicating a drop in MADRS scores by at least half and remained in the same range over time. On the other hand, 10.1 percent of the placebo group showed a sustained response.?
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But not all was positive. During the trial, 12 participants experienced a serious adverse event like suicidal behaviour, intentional self-harm or suicidal ideation -- five of these participants came from the 25-milligram group, six were in the 10-milligram group and one was in the 1-milligram group.?
However, since the number of people who experienced these effects was small, they don’t mark a statistically significant difference. However, Compass Pathways plans to assess the data in detail to look for possible links between psilocybin dosage and suicidal tendencies.?
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Based on the almost positive results the company is moving ahead with a late-stage clinical trial of the aforementioned drug, preferably in the 25-milligram configuration, however, regular approval is still pending.?
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