Psyched Wellness Ltd. has initiated the first steps towards a clinical sleep study for a structure/function claim for its proprietary extract (AME-1) from Amanita Muscaria mushrooms.
The company said the aim of the study is to carry out an assessment of a novel sleep-enhancing food supplement for self-declared insomniacs based on both subjective and objective sleep measures, including residual effects.
Several conventional and over-the-counter sleep medications have residual effects and drowsiness. Psyched Wellness said it plans to develop new treatments that show a lack of residual hangover effects and increased alertness during the day.
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The study will be led by Psyched Wellness board member and head of its scientific committee, David Nutt, who is a psychiatrist and the Edmond J. Safra Professor of psycho-pharmacology at Imperial College, London and the chair of the scientific advisory board for COMPASS Pathways.
“Psyched Wellness is researching the hugely important field of sleep and its disorders, and the Company’s proprietary AME-1 has the potential to assist with these,” Nutt said in a statement. “Positive results from this clinical study will allow the Company to write a claim on the future AME-1 supplement that the product can help with sleep while also improving daytime functioning.”
The team for the study also includes:
- Chris Alford -- Associate professor of Psychology at the University of the West of England where he leads a group measuring the impact of drugs and other variables on cognitive processes, especially sleep and driving. Alford is an advisor to the UK government on transport safety issues especially self-driving cars and advises on issues relating to the cognitive impact of medicines on these issues.
- Sue Wilson -- One of the UK's leading human EEG and physiological measurement experts for which she is much sought after by pharmaceutical companies doing Phase 1 research using sleep as a measure of drugs effects. She led the recent BAP consensus review of the treatment of sleep disorders.
- Claire Durant -- After completing her Ph.D. in EEG sleep recording at Bristol University, she joined DJN psychopharmacology team running human experimental studies on various GABAergic agents using sleep EEG and fMRI measures of effect.
“Completing the sleep study and obtaining a structure/function claim for AME-1 is a very significant milestone, not only for the Company but for everyone that suffers from insomnia and sleeping disorders," said David Shisel, COO of Psyched Wellness. “Developing a natural Amanita Muscaria Mushroom food supplement that has been clinically proven in human trials to help with sleeping disorders is very promising to the Company and to consumers worldwide.”
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