Author: dailymushroom

Published at truffle.report.com.

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By TANYA IELYSEIEVA

Panellists at the Mydecine Speaker Series last week highlighted the present and future potential of psychedelic therapies in relation to the mental health crisis.

The panel was hosted virtually on December 15 by the Microdose Psychedelic Insights and was moderated by Business Insider journalist Yeji Lee.

Panellists included Ruth Lanius, Professor of Psychiatry and director of the PTSD research unit at the University of Western Ontario, Robin Carhart-Harris, head of Centre for Psychedelic Research, Imperial College London and Mydecine’s scientific advisory board member, Rakesh Jetly, OMM, CD, MD, FRCPC, and Mydecine’s Chief Medical Officer, Robert Roscow, Chief Scientific Officer and Co-Founder of Mydecine.

Mental Illness and The Function of Psychedelics as Treatment

Lee began the panel by asking participants for their thoughts on how recent studies shed new light on both mental illness and the function of psychedelics as treatment, and what technologies and methods, in particular, have had an impact on the field.

Lanius spoke about how recent developments, both for psilocybin and MDMA, have shown some promising effects in treating PTSD and depression. Lanius, who has spent the last two decades researching what happens in the minds and bodies of traumatized individuals, added that from her personal experience, “some clients, who’ve tried a lot of therapeutic modalities, have found the psychedelic treatments most beneficial. That’s not for all, but that’s certainly for some.”

“We often see in psychiatric disorders that the brain gets locked in certain patterns, and I think that promotes the distress individuals feel. And there’s a hypothesis, of course, that the psychedelic treatments can push people out of these locked places in the brain and reset the brain,” Lanius said.

Jetly, who has been a psychiatrist with the Canadian Armed Forces for 20 years, stressed that medical workers, who start their careers, are committed to evidence-based treatments, including cognitive behavioural therapy. However, as they get older, doctors start noticing where the evidence-based treatments end, who it doesn’t help, and why it doesn’t work.

“If we’re lucky in PTSD’s conventional treatments, medication and psychotherapy, it helps 50-60 percent of people. It’s a huge number of dropouts, and it’s extremely difficult,” Jetly said.

“I’ve been searching for the last decade for what else we can offer people when the evidence-based treatment doesn’t work. That’s why, scouring, looking for the evidence and looking for compelling research, it’s hard to ignore the quality research that’s being done in this space, whether it’s psilocybin, whether it’s MDMA. I think, for me, that’s trying to find something else that we can offer people that can help them,” he continued.

Psychedelic Research is ‘Not Shady Stuff Around The Corner’

Responding to a question by Lee about why there’s been a halt on new developments around mental health medications and treatments, Jetly said it is important to demonstrate the safety and efficacy of these psychedelic substances and to convince the regulatory bodies that this is “not shady stuff around the corner and this is completely above board.”

Lanius, agreeing with the comment by Jetly, said, “It’s so important to do these studies in a very meticulous, a very scientific way, and to follow people as long as we can to see the long-term effects. We can examine the long-term effects. I think people will want to know that, tracking what happens neurobiologically but also on a bodily level. Because that trauma has a big effect on the inflammatory markers, I think people will be curious to see if we can change mind, brain and body with these treatments, how can we change them and how long does it last.”

Roscow added that the most interesting aspect of this research is that these psychedelic substances address multiple systems and are active not only in the nervous system but in the digestive system, immune system, as inflammation response, and it is “an open question in this area of research as to how that branches into other conditions or helps more nuanced ways addressing the primary conditions like PTSD and depression.”

Psychotherapy and Psychedelic Treatment

As the discussion moved forward, Lee asked panellists about the process of psychedelic-assisted psychotherapy.

“There are different phases of it. There’s the preparation phase that, in my opinion, needs to look as closely to the psychedelic as possible. Things are very predictable for the client when they have these hallucinatory experiences and enter this different world. They’ve been grounded in the first session, pre-psychedelic, and that gives them a foundation and a holding environment to have this experience. During the psychedelic experience, the therapist again provides a container holding environment and provides safety for the patient to be able to form new connections, to reflect, and to experience new things,” Lanius explained.

“There’s also a place to start thinking about the follow-up care and how we can approach the follow-up care now that the individual sense of self is shifted. They’ve experienced new things, new avenues have opened up for them. How do we continue to process that with an individual? To foster a new sense of being in this world, which I think is something we want to achieve through good treatment,” she continued.

Jelty agreed to Lapius’s point and stressed out that “you want to guide, but you don’t want to get in the way.”

Pivotal Mental State and a Path for Treatment

According to Carhart-Harris, who has been researching psychedelics for 15 years, a pivotal mental state is referring to a few key criteria.

“One is that these states are hyperplastic. So, within these states, there is an exceptional ability for the mind, the brain and behaviour to be changed in relation to the conditions that those systems are in during that period. Also, those changes can be particularly marked or dramatic,” Carhart-Harris explained.

“What I discovered, while researching around this, was that stress is a particularly reliable condition in which these pivotal mental states defined by hyper plasticity, sensitivity to context and an upregulation of the serotonin receptor system, stresses a reliable natural way of inducing these states. And that makes sense to me in terms of the phenomenology around transformative psychological experiences that are often preceded by crisis, intense stress and prolonged stress. For me, working these things out, it’s a hypothesis and it’s there to be tested, and help me understand why we might have this system in our brains and bodies that can be engaged in the particularly challenging conditions where a period of intense plasticity might help us. Because maybe our lives depend on our ability to be exceptionally adaptive because whatever strategies, cognitive, behavioural aren’t working, maybe our life is in danger in some way, and something needs to give, something needs to change. It’s sort of understanding outside of the context of psychedelics; what can happen in the brain, what changes, what processes can play out that induce something akin to a psychedelic like experience that seems to engage the same pharmacological and other neurobiological mechanisms that psychedelics kind of hack, or hijack,” he continued.

The Rise of Interest and its Impact on Modern Society

Answering the question about the current state of psychedelic interest, Lanius said people feel “really stuck” with the current treatments.

“We’ve got some great treatments. However, a lot of people don’t progress, and a lot of people drop out. I think people are feeling stuck, they are feeling frustrated, and I think they’re ready to explore something new,” Lanius said.

Roscow, agreeing with Lanius, said, “That couldn’t have necessarily happened without the increase in the quality of the data that’s been associated with it. There’s been strong hints and strong pieces of data out of a piecemeal of research over the last 50 years, and because the quality of the data is caught up with it, I think it’s becoming much harder to argue against and that aspect that balance is what I see a shift in.”

Carhart-Harris said that he is “very much enjoying the present mainstreaming of things.”

“It’s affirming. I remember the days of speaking to people at conferences where they would scoff at the triviality of studying how psychedelic drugs work in the brain. It is great, and it translates into more resources to do research, to ask more questions, and indeed, build that critical mass of evidence,” Carhart-Harris said.

“There’s a lot of this to be processed, nuances in relationships and new ways of thinking about mental health itself, as well as interventions for mental health. I do believe it’s very healthy. Having done a trial where we’ve gone head-to-head with conventional treatment for depression, that’s helped contextualize for me quite how different psychedelic therapy is to standard antidepressant medication, for example,” he continued.

Jelty believes that psychedelic research gave a voice to the patients as well.

“We’ve increased awareness of mental illness; it’s come out of the shadows. So, guess what, at a point, it was no longer stigmatizing and even talked about it. But beyond talking about it, they’re now demanding, they, sort of saying, ‘what you are giving us is not good enough’,” Jelty said.

Published at globenewswire.com.

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DENVER, Dec. 21, 2020 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has engaged ethica CRO (“ethica CRO”), a full-service Contract Research Organization (“CRO”) that conducts and manages ethical clinical research on drugs, biologics, medical devices and more, as the contract research organization (“CRO”) for its upcoming Phase 2A PTSD clinical trials.

ethica CRO is a full-service, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. ethica CRO provides a complete range of clinical study management and biometrics services for clinical research phases I through IV. Since its inception in 2002, ethica CRO has dedicated its efforts to bring a new dimension to the clinical research industry, the ethical dimension, focused on integrating research participants as partners in research rather than simply subjects of research. ethica CRO was the first CRO in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies

“We are excited to bring on a high-caliber partner in ethica CRO, which has extensive expertise in managing clinical studies to the highest standards of ethical and clinical practice, as the CRO for Mydecine’s upcoming Phase 2A PTSD clinical trials,” commented Josh Bartch, CEO of Mydecine Innovations Group. “Engaging ethica CRO is one of the key pieces of our preparations as we explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Mydecine’s clinical development. We believe that with ethica CRO’s deep clinical experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase 2A PTSD clinical trials in Veterans in Canada and the United States.”

ethica CRO’s dedication to research participant protection made it a partner of choice for the Canadian Department of National Defence. ethica CRO has participated in a series of clinical development programs with the Canadian DND and various NATO allies, most notably synthetic cannabinoids in the treatment of PTSD, injectable antidotes to chemical weapons, and skin decontamination kits for neutralizing chemical warfare agents.

“Psychedelics and psychedelic-assisted therapies are rapidly proving to be some of the most exciting developments in mental health treatment in decades,” said Murray Jensen, Managing Director of ethica CRO. “Mydecine’s ambitious approach to researching and tackling the mental health challenges facing veterans and other frontline workers aligns with our values and mission at ethica and we are excited to hit the ground running with the Mydecine team as they push forward in their pursuit to transform mental health.”

Mydecine’s international Phase 2A clinical trials will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at Leiden University Medical Centre in the Netherlands; the University of Western Ontario; and the University of Alberta, with other clinical sites on the horizon in the USA, Europe, and Australia. Through these trials, Mydecine hopes to establish the safety and efficacy of psychedelic administered psychotherapy in a safe and supervised setting, utilizing strict protocols approved by research ethics boards and build upon the body of work that has led to psilocybin-assisted psychotherapy to receive “breakthrough” status by the FDA.

About Mydecine Innovations Group
Mydecine Innovations Group™ is an emerging biopharma and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health challenges and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is advancing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada. Mydecine’s portfolio companies Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ position the company at the forefront of disruptive modern medicine.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

About ethica CRO Inc.
Founded in 2002, ethica CRO is a full-service contract research organization (CRO) that conducts all clinical phases of ethical research for new and innovative treatments on behalf of the pharmaceutical, biotechnology, medical device and natural health product industries. ethica CRO was the first Contract Research Organization (CRO) in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies. Human research protection program (HRPP) accreditation by an independent, industry-recognized organization confirms that an organization’s processes ensure the respect and protection of research participants, and that its services meet or exceed industry standards.

Learn more at: www.ethicaCRO.com and follow us on Twitter and LinkedIn.

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