While the use of psilocybin and the development of psychedelic-based drugs and therapies are increasing, the evidence on how they work and affect us is still relatively under-researched, thanks to decades of prohibition.
However, the recent publication of the results of the largest psilocybin study ever completed may help us better understand the potential of this compound.
Recent research has revealed that these results showed a “rapid and sustained response” for patients receiving a psychedelic-based drug.
According to the company, the drug could reduce the symptoms of treatment-resistant depression may decrease after three weeks, making it a potentially useful therapeutic option for treating the condition.
What is psilocybin?
Psilocybin is a psychedelic compound found in a small number of fungi, known as 'magic mushrooms'.
These mushrooms have become well known, but in the past half decade they have largely been associated with recreational drug use, hippie culture and anti-establishment groups.
There is relatively little awareness of the health and therapeutic potential of the substance.
About treatment-resistant depression (TRD)
More than 320 million people worldwide suffer from major depressive disorder (MDD), the leading cause of disability worldwide and one of the fastest growing mental illnesses.
About a third of these patients – about 100 million people – are not helped by existing therapies and suffer from treatment-resistant depression (TRD).
TRD carries two to three times the medical cost of treating non-TRD MDD, and patients with TRD have a higher all-cause mortality compared to non-TRD MDD patients.
What did the study find?
In this recent randomized, controlled, double-blind study, a single dose of an investigational psilocybin-based drug was given to 233 patients along with psychological support from specially trained therapists.
The trial was designed to compare two active doses of COMP360, the drug, 25 mg and 10 mg, to a 1 mg dose of a comparator.
The results are telling: The 25 mg group versus the 1 mg group—basically the placebo group—showed a difference of -6,6 on the Montgomery-Asberg Depression Rating Scale (MADRS) depression scale at week three.
However, there was no real difference between those who received 10 mg of COMP360 and 1 mg of comparator.
In addition, nearly every third (29%) of the 25 mg group reported some sort of remission after three weeks — with nearly a quarter of the same group still in remission 12 weeks after dosing.
These are promising results to say the least.
David J Hellerstein MD, principal investigator of the trial and professor of clinical psychiatry at Columbia University Irving Medical Center, said:
“Treatment-resistant depression is a common and devastating condition that affects tens of millions of people with few effective treatments.
This is the largest modern study of a psychedelic drug combined with psychological support, enrolling more than 200 people with TRD. In this groundbreaking study, a single dose of psilocybin given in combination with psychological support generated a rapid response that lasted for up to 12 weeks.
Remission rates appear to be higher than in traditional drug studies. We now have evidence from a large, well-designed study that psilocybin may be effective for people with treatment-resistant major depressive disorder.
“These findings suggest that COMP360 psilocybin therapy could play an important role in psychiatric care, if approved.”