(Part four of a four part series)
See previous stories:
- Psychedelics and Treatment-Resistant Depression: An Overview of the Latest Study Findings from COMPASS
- Psychedelics and Treatment-Resistant Depression: Responses to the Published Findings of COMPASS
- Psychedelics and Treatment-Resistant Depression: Companies are addressing the important issue
To bring all sides of the issue to the table and get a clearer understanding of what the results are COMPASS ways CMPS‘ Latest phase 2b trials mean Benzinga interviewed Dr. Steve LevinSVP of Patient Access and Medical Affairs, who works closely with PI Dr. Guy Goodwin on the study.
One of the main concerns about these studies centered on what appeared to be “unequal proportions of major depressive people” within the three dose groups, noting that the 25 mg arm would have included “significantly fewer” participants in this population.
Levine recalled that the study’s primary endpoint in terms of interpretation was change in MADRAS depression score from baseline up to three weeks, and taking this into account, the top-line results showed that there were no significant differences in the mean three 25mg, 10mg and 1mg groups.
“Special, Additional table 4 shows that baseline MADRAS severity did not affect efficacy in this primary endpoint. So I question the interpretation of what the critic is looking at, because within a study you can see some differences in the raw numbers, but that’s different from what’s statistically significant, which is actually demonstrably due other than chance and actually affect the outcome,” Levine told Benzinga.
While the study revealed some numerical differences in the mean baseline MADRAS scores, the evidence in Table 4 shows that these were not conclusive across groups, and the severity of the baseline MADRAS score did not correlate with the clinical efficacy of psilocybin, he explained.
A second review stood out in the form of an accompanying one editorial in medical…
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