by According to a new study, a small dose of psilocybin, a drug derived from magic mushrooms, along with psychotherapy can significantly reduce symptoms of severe depression in patients.
The research, published in New England Journal of Medicineevaluated data from 233 participants with treatment-resistant depression in a clinical study of 22 international sites in 10 countries in Europe and North America, including the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London.
“While many patients with mental health problems improve with the treatments available, a subset of patients do not even if they try many different forms of treatment. This is sometimes called ‘treatment resistance’, ”explained James Rucker, one of the study’s co-authors.
Nearly 100 million people worldwide suffer from this form of severe depression, in which patients have failed to respond to at least two antidepressant treatments for their major depressive disorder.
As treatment options for this group of people are limited, scientists say new paradigms are needed for treating these patients and clinical research on the serious condition.
While a growing body of research points to the positive effects of psilocybin treatment on mental health, researchers say its effects need to be tested in larger clinical trials.
The researchers looked at the change in depression severity in study participants with treatment-resistant depression over the course of 12 weeks after a single dose of psilocybin COMP360 was given along with psychological support.
Patients were randomly assigned to a single dose of 25 mg, 10 mg, or 1 mg of psilocybin COMP360, along with psychological support.
Participants who received the 1 mg dose acted as a control group.
Participants were assessed on the severity of their depressive symptoms one day prior to psilocybin COMP360 administration, along with follow-up assessments on day two and weeks one, three, six, nine, and 12.
Participants reported a greater reduction in depression three weeks after taking a single 25 mg dose of psilocybin COMP360, compared to those who took the lower 1 mg dose.
“This study, which is by far the largest clinical study on the use of psilocybin for treatment-resistant depression to date, showed that a single 25 mg dose of psilocybin improved participants’ symptoms of depression compared to a dose of 1 mg (control). These results are a positive step in the right direction, “said Dr. Rucker.
The effects lasted between six and eight hours. During this time there was also a therapist in the room with the participants to provide psychological support.
“In this phase 2 study involving participants with treatment-resistant depression, psilocybin in a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1 mg dose over a period than 3 weeks, but it was associated with adverse effects, “the scientists wrote in the study.
There were also some adverse effects reported by participants, such as headache, nausea, dizziness, fatigue, and thoughts of suicide in all dose groups.
About 84 percent of patients in the 25 mg dose group reported headache, nausea, dizziness, and fatigue, the study noted.
This fraction was 75% in the 10 mg dose group and 72% in the 1 mg dose group, the scientists added.
“Suicidal ideation or behavior or self-harm occurred in all dose groups,” the scientists noted, adding that these symptoms are common in treatment-resistant depression studies.
However, they say the findings point to the potential recognition of psilocybin COMP360 as a new treatment option for treatment-resistant depression.
“We look forward to starting our Phase 3 program later this year, moving closer to providing psilocybin COMP360 with psychological support for patients in dire need,” said Guy Goodwin, another co-author of the report. study.
“Larger and longer studies, including comparisons with existing treatments, are needed to determine the efficacy and safety of psilocybin for this disorder,” the researchers added.
