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(Part one of a four-part series)
COMPASS Pathways Results CMPSA phase 2b trial evaluating the safety of different doses of proprietary synthetic psilocybin combined with psychotherapy for treatment-resistant depression (TRD) was recently published in the New England Journal of Medicine.
The study took place at 22 sites in the US, Canada, UK and seven European countries and recruited 233 participants with TRD, meaning they had failed to respond to two treatments previous antidepressants.
Noting data that approximately 100 million people worldwide have TRD, and of the nine million in the United States with medically treated depression, approximately one-third, or three million, are resistant to treatment. As the publication explains, people with this condition are at high risk for physical illness, disability, hospitalization and suicide.
Double-blind and randomized, the trial divided participants into three groups, corresponding to a single administration of COMP360 at doses of 25 mg, 10 mg or 1 mg (control), accompanied by psychological support.
As indicated, this is the largest psilocybin trial published to date and the second major psilocybin study published in the prestigious journal (after 2021’s psilocybin versus escitalopram.)
Results after single administration included immediate improvement in depression scores for most patients in all groups, showing profound antidepressant effects for those in the 25 mg dose group.
After 3 weeks, 29% of subjects in the 25 mg dose group, 9% in the 10 mg dose group and 8% in the 1 mg dose group were responders. The first figure, although relatively high, is lower than that described for first-line treatment of major depressive disorder (MDD) in large trials of citalopram and other conventional antidepressants, but higher than second-line treatments. intention.
At week 12the number of responders in the high dose group was 20% and 10% in the lowest dose group.
On the other hand, adverse events occurred in 77% of the total number of participants in the three groups; these included headache, nausea, dizziness, fatigue, and in some cases suicidal ideation or behavior or self-harm – rates of suicidality were seen in participants at 1% to 1mg , 4% at 10 mg and 5% at 25 mg.
The study authors said larger, longer trials, including a comparison with existing treatments, are needed to further determine the efficacy and safety of psilocybin for TRD. Indeed, longer-term follow-up of these patients will be essential to establish the durability of the effects of psilocybin therapy.
In this sense, COMPASS is already ready to conduct larger phase 3 trials exploring the effects of two doses of psilocybin starting in December 2022. Planned to include more than 900 participants in 14 countries, the study is expected to end in by mid-2025.
Next : Psychedelics and Treatment Resistant Depression: Reactions to Published Findings
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