Don’t Freak Out. It Isn’t the End of the Line for Psychedelic...

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Breakingsystem

415 Posts.

164

07/06/24

13:24

Post #: 74215417
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Originally posted by Flectional: ↑

your take is interesting in a number of areas - and not accurate dc

the fact that the recipient can identify they have taken a sugar pill ( in this particular case) rather than the drug under trial does not indicate an adverse outcome for the trail endpoints - rather the reverse is true and substantially so - to undergo the psychotherapy set after taking the trial medication and finding no differentiation or change in the patient condition would indicate immediately to the patient they have been dosed with an ineffective medication ....in this case a sugar pill.
This is exactly what you would want if you were conducting the trial - why? this is the opposite of the placebo effect verifying the test cohort outcomes comparative to the outcomes of those on the real medication.

the FDA committee indicated major failures with the trial design that Lykos conducted - blinding protocols being a major factor - as a result blinding must be administered, scrutinized and meticulously aligned with the psychotherapy set for quality data to be in evidence - this was not the case with this Lykos trial - as the FDA stated they in fact ignored procedural recommendations by the advisory contributing to the trial failure.

Clarion outcomes to date (Dr Paul and PSI -GAD) have had no such issues
PsiGAD-1 is a randomised triple-blind active-placebo-controlled Phase 2 trial. The primary objective of the study is to determine whether a 7-week program of psilocybin-assisted psychotherapy for GAD is superior to active placebo-assisted psychotherapy in decreasing symptoms of GAD, as measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 11. Safety and tolerability were assessed, as well as other secondary objectives of efficacy and quality of life.

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Don’t Freak Out. It Isn’t the End of the Line for Psychedelic Medicines

https://www.barrons.com/articles/mmda-ecstacy-psychedelic-medicines-fda-7130bf1c

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