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Offlinepolaritymind
relaxed attention
I'm a teapot

Registered: 10/10/16
Posts: 757
Loc: Europe
Last seen: 1 day, 16 hours
German Psilocybin Study Approved by BfArM
    #27046982 - 11/19/20 11:40 AM (7 days, 13 hours ago)

https://www.mind-and-brain.institute/psychedelics/german-authorities-approve-psilocybin-depression-study/
https://mind-foundation.org/psilocybin-depression-study/

After almost two years of hard work (unbelievable from the outside) we finally made it! Yesterday – November 17th, 2020 – we were notified that the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) approves our study on the “Efficacy and Safety of Psilocybin in Treatment-Resistant Depression” (Acronym: EPIsoDE). The study had already been approved by the ethics committee II of the University of Heidelberg a couple of days ago.

German authorities approve psilocybin depression study

Our preparations for the study are ongoing, funding from the Federal Ministry of Education and Research (BMBF) most likely begins on March 1, 2021 (I reported on this major accomplishment in my post on April 24, 2020). We will provide details of the study on a dedicated study website, which will go online shortly. For me personally, the study represents a milestone for German psychiatry, from which I expect not only impulses for treatment research, but also insights into the nature of mental illness and the foundations of consciousness.

Today I would like to express my sincerest gratitude to all those who have contributed to this success:

First and foremost, Lea Mertens, a young psychologist and doctoral student in my department, has to be mentioned. While I was keeping “the big picture” in mind, she took care of all the details – and there really were a lot. Without her we wouldn’t be where we are today. She is a wonderful person and I’m sure that she has a great career ahead of her as a psychotherapist and scientist. I’m glad that she joined me at the ZI two years ago.

I would like to thank the colleagues in the team in Berlin, both from the Department of Psychiatry and Psychotherapy at the Charité Berlin, Campus Mitte (Michael Koslowski, Tomislav Majic, Felix Betzler, Ricarda Evens, Lea Mascarell-Maricic and Andreas Ströhle) and from the MIND Foundation (Andrea and Henrik Jungaberle, Max Wolff). We as a team, also including ZI psychiatrist Maria Gilles, developed a study protocol and treatment manual at the highest methodological level.

I would also like to thank the employees of the USONA Institute in the USA. USONA will provide us with the psilocybin for our study. Tura Patterson, Laura McCormick, Nicole Smialek and Kelsey O’Hern have done a lot to ensure that we will have GMP quality psilocybin in just a few weeks to safely treat our patients.

My big thanks also go to Marija Tubic from the pharmacy at Mainz University. Getting psilocybin in GMP quality is one thing; making investigational drugs out of them that patients can receive in a clinical trial is another. Marija Tubic has dedicated herself to this with great commitment and true competence.

I would like to thank the CEO of the Central Institute of Mental Health (ZI), Andreas Meyer-Lindenberg, for supporting me in touching the “hot iron” of psychedelic research. That is not a matter of course at a German university, and I know that it would not have been possible everywhere in Germany. I am proud to be a ZI researcher and to have opened this important gate here. Thanks are also due to the administration of the ZI, the third-party funding department and the legal department, who supported us in all administrative processes. People there were sometimes desperate about my demands and wishes. An official press release will be published tomorrow by our communications department.

I would like to thank the assessors of the BfArM for their generous advice on preparing for the study and the fair assessment of our application, and I thank the members of the ethics committee for the intensive discussions and the openness towards this promising therapy option.

Funding for our study has not yet started, but I would like to thank those responsible in the Federal Ministry of Education and Research for supporting this project, which is particularly important to me. Our study will be one of the largest and most extensive that has ever been carried out with a psychedelic. That a German government is making progress in promoting this research is a great signal to the world.

Finally, my heartfelt thanks go to Andrea and Henrik Jungaberle, the founders of the MIND Foundation. I learned from these two enthusiastic people that this is about more than just clinical testing of a substance. It is about the creation of an ecosystem and a culture of altered states of consciousness, it is about questions of being human and a better life for every being. Together we went on a journey to create something that addresses all of these questions (including the foundation of OVID Health Systems). Today I have a real friendship with Andrea and Henrik, for which I am very grateful. And I thank the team members of the MIND Foundation, which I met over the last year, many great people who are dedicated to the advancement of humanity.


--------------------
"to affirm life is to also affirm death"
-Albert hofmann


Edited by polaritymind (11/19/20 11:47 AM)


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OfflineMrToon
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Registered: 12/03/19
Posts: 16
Loc: Texas
Last seen: 20 hours, 33 minutes
Re: German Psilocybin Study Approved by BfArM [Re: polaritymind]
    #27047190 - 11/19/20 01:28 PM (7 days, 12 hours ago)

Spreading across the world! It feels like we're on the tipping point now doesn't it?


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OfflineHolybullshit
Stranger
Registered: 01/06/19
Posts: 613
Last seen: 7 hours, 17 minutes
Re: German Psilocybin Study Approved by BfArM [Re: MrToon]
    #27047633 - 11/19/20 06:17 PM (7 days, 7 hours ago)

Of psilocybin/tryptamines being employed/developed for use in treating mental health, maybe, but I wouldn't get my hopes up on this having a big affect on the drug war. It's progress, and I hope lots of people benefit from it...but I'm too old and cynical to believe in drastic change in the right direction anymore.


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Offlinemusiclover420
psychonaut
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Registered: 11/06/12
Posts: 19,562
Loc: PNW
Last seen: 1 day, 9 hours
Re: German Psilocybin Study Approved by BfArM [Re: Holybullshit]
    #27047716 - 11/19/20 07:17 PM (7 days, 6 hours ago)

Quote:

Holybullshit said:
Of psilocybin/tryptamines being employed/developed for use in treating mental health, maybe, but I wouldn't get my hopes up on this having a big affect on the drug war. It's progress, and I hope lots of people benefit from it...but I'm too old and cynical to believe in drastic change in the right direction anymore.




Oregon just passed 2 bills, one is for medicinal psilocybin mushrooms and the other decriminalizes pretty much all drugs state wide and calls for increased treatment options.

Soon people in Oregon will be able to apply to become a state approved mushroom manufacturer and grow mushrooms for therapists to give to approved patients for medicinal use.

We'll see how well both bills end up being implemented but it's hard not to be excited for the possibilities.

Other places have already decriminalized mushrooms as well. So while progress has been slow it does seem to be ramping up again.


--------------------
Don't worry about me, I've got all that I need. And I'm singing my song to the sky

You know how it feels, With the breeze of the sun in your eyes. Not minding that time's passing by

I've got all and more, My smile, just as before. Is all that I carry with me

I talk to myself, I need nobody else. I'm lost and I'm mine, yes I'm free



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InvisibleLanc3r117
Rain
Male User Gallery


Registered: 10/10/08
Posts: 278
Loc: PNW
Re: German Psilocybin Study Approved by BfArM [Re: MrToon]
    #27047889 - 11/19/20 08:52 PM (7 days, 4 hours ago)

Quote:

MrToon said:
Spreading across the world! It feels like we're on the tipping point now doesn't it?




I read this as tripping point :grin:

And if OR decrim bill has possession limits based on weight, then that's def not as cool for hunting wet mush as I would have hoped.


Edited by Lanc3r117 (11/19/20 08:55 PM)


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OfflineGermanShaman
Stranger
Registered: 01/05/18
Posts: 65
Last seen: 5 hours, 58 minutes
Re: German Psilocybin Study Approved by BfArM [Re: polaritymind]
    #27054893 - 11/24/20 05:48 AM (2 days, 19 hours ago)

Well done on gettnig approval.

I look forward to the results.


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