As our social fabric is unraveling and rates of depression continue to rise, affecting an estimated 310 million people worldwide, psilocybin research has given us a glimmer of hope that things may be changing for the better.
The largest Phase 3 clinical trial investigating the safety, efficacy, and tolerability of psilocybin as a treatment for treatment-resistant depression (TRD) has finally begun.
In late 2022, Compass Pathways announced that their Phase 3 program, consisting of two separate pivotal studies involving a total of 946 participants and one long-term follow-up study, would be launching.
In November 2022, the company’s first pivotal study (COMP 005), involving 378 participants, began recruiting subjects. However, the actual study didn’t begin until January 19, 2023. The study aims to compare a single 25mg dose of COMP360 synthetic psilocybin paired with psychological support with a placebo, with the hope of replicating its positive Phase 2 results. 2. This first study is expected to conclude in October 2024.
Overall, 378 participants will be randomized in a 2:1 ratio to receive COMP360 25 mg or placebo. Source: ClinicalTrials.gov
In February 2023, the company began recruiting for its second pivotal study (COMP 006) and is expected to complete the study by May 2025. In this study, 568 randomized participants will receive COMP360 25 mg, 10 mg or 1 mg with the goal to examine whether a second dose could increase the number of people with positive responses to psilocybin therapy or improve the response seen in the Phase 2b study. The study also aims to investigate the potential for a “significant treatment response from repeated administration of COMP360 10mg”.
Overall, 568 participants are to be randomized in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg. Source: ClinicalTrials.gov
According to ClinicalTrials.gov both studies are still recruiting participants, which means people diagnosed with treatment-resistant depression looking to find free, legal psilocybin treatment might be in luck!
What we know so far from Compass’ Phase 2b study involving 233 participants treated with a 1mg, 10mg or 25mg dose of COMP360 is that most patients’ depression scores improved markedly after a single dose. of psilocybin with 30% of patients in remission. at week 3. Not surprisingly, those receiving the highest dose of COMP360 showed the most significant improvement in symptoms.
However, what we also know is that 12 weeks later, only 20% of subjects given 25mg of psilocybin still had a sustained response, indicating that psilocybin’s efficacy wears off after 3-12 weeks for those experiencing TRD. Naturally, those who had hoped for a single magical bullet were disappointed.
Needless to say, these results explain why Compass Pathways is conducting their second pivotal Phase 3 study. It appears that repeat treatments may be necessary for severe cases. Fingers crossed, we will be able to see positive results above 30% with the Phase 3 study.
To conclude on a positive note, although the possibility that a single large dose of psilocybin combined with psychological support may not deliver the stellar results we all hoped to see for treatment-resistant depression, it could be a solution for depression in sufferers of cancer. Last week, the Phase 2 study initiated by Sunstone Therapies researchers to evaluate the synthetic psilocybin COMPASS Pathways announced some impressive long-term follow-up data. A single 25 mg dose of psilocybin along with therapy led to a sustained remission of depression in 57% of patients, with 64% experiencing significant improvement 18 months later.
Read also: A single dose of psilocybin causes long-term remission of depression in over 50% of cancer patients
The psychedelic industry is going to experience some significant changes over the next couple of years. Starting July 1, Australia will start treating PTSD with MDMA and TRD with psilocybin. We also expect positive results from MAPS’ Phase 3 MDMA study for PTSD that could lead to FDA approval for MDMA therapy later this year. Meanwhile, more and more psychedelic treatment centers will begin opening in Oregon and Colorado as psychedelic reform efforts in the United States continue to progress. If Compass’ Phase 3 clinical trial provides positive data, we could even see FDA approval for psilocybin therapy in 2025. As Violet Vane once said, “Good things come to those who wait.”
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