Psychedelic treatments for depressed mums
A new trial of 5-meo-DMT without therapeutic support has raised safety and ethics questions
This article discusses suicidal thinking.
In 2017 Melissa Lavasani gave birth to her second child. Six months later, she wanted to kill herself. She’d experienced some depression in the late stages of the pregnancy, but it got way worse after the birth. It was the combination of the sudden drop in hormones, the crushing tiredness, the crying baby, and the jarring distance between how she felt and how people expected her to feel.
She tells me:
There’s this sadness and despair, and also this element of ‘I got what I wanted, and I’m not happy, maybe this isn’t what I wanted and I’ve made an irreversible mistake?’ There’s a lot of societal pressure on women to be a certain way when you’re a new mom and love every minute of it, and a lot of shame if you’re not.
When she went for the regular visits to her doctor, he would always ask how she was feeling, and she could tell him - not good. She was offered the standard treatments for post-partum depression: anti-depressants and CBT. But she didn’t want to take anti-depressants while she was breast-feeding.
And honestly, therapy is only as good as what you can put into it. I was in such a state of mind that the idea of doing my CBT homework…forget about it.
After two years of this depression, Melissa was fighting serious suicidal ideation, which began six months after the birth.
The suicidal thinking went something like this: I have such an amazing, beautiful family. it's such a shame that it's going to waste on a woman like me. Surely there's another woman out there that can be the mom. I convinced myself this is the right thing to do. I knew a friend who killed herself, she was a mom and had suffered from post-partum depression for a decade. And I didn’t understand how she could do that to her loved ones. Now I understand that, when you have suicidal ideation, you think this is a selfless act. You are the problem in this situation, and you're removing it.
In 2019, her husband (who likes taking psychedelics and listening to jam bands) convinced her to try microdosing magic mushrooms. She did, and three days later she played with her son on the floor and actually enjoyed it and emotionally engaged with him. The positive results from microdosing persuaded her to take a bigger jump and try a macrodose - not of psilocybin but of ayahuasca. She took the train up to New York on her own. (‘I would not have been able to do that if it wasn’t for the microdosing’.) and went to an apartment in Brooklyn where a shaman led a one-night ayahuasca ceremony.
I dived right in to the deep end. It was the most insane experience for me. It was extremely physically painful and emotionally gut wrenching. But I felt I had to get it out, and I had an epiphany. The suicidal thinking went immediately.
She came back home to DC and her husband looked at her when she came through the door. ‘He could immediately tell my energy was different.’ She did two things that helped her recover more fully. One was that she was able to engage with therapy. And the other was she removed an IUD she’d had inserted, which she had suspected was playing havoc with her hormones - her epiphany on the ayahuasca was she should remove it.
Melissa became a powerful advocate for psychedelics in DC. First she spearheaded the campaign to decriminalize plant medicines in DC in 2020 - one of the first successful psychedelic decriminalization measures - and then she established the Psychedelic Medicine Coalition to lobby the federal government to promote psychedelic treatments.
5-meo-DMT for mums with post-partum depression?
It’s quite common for mums to feel the ‘baby blues’ for a few weeks after birth, partly as a result of sudden changes in their hormones. But that can stay for longer and become post-partum depression, which can affect around one in ten women, according to the NHS. It can take the form of anxiety, insomnia, paranoia, or even psychosis. There are some recommended treatments - CBT and anti-depressants - and 80% of mums achieve a full recovery. But still, this is an awful condition that affects many mums.
Could psychedelics offer a new treatment?
Two biotech companies are developing psychedelic treatments. One is Reunion Neuroscience, a US company which raised $100 million in May to fund its Reconnect trial of a psilocybin-like substance for post-partum depression. It is partnering with multiple universities across the US for its trial and recently treated its first patient.
The other is GH Research, a company based in Ireland, which has raised around $300 million, making it one of the biggest psychedelic companies out there - though like many psychedelic biotechs it keeps a low profile and avoids the limelight.
GH Research is about to begin a trial for post-partum mothers using 5-meo-DMT, the fast-acting, short-lasting so-called ‘God molecule’ which derives from the Bufo Alvarius toad. It’s a small trial of just eight patients, who will each be given a high dose and then further doses if ‘peak experience’ is not achieved. The trial is being run by Clerkenwell Health and St Pancras Clinical Research, two London-based psychedelic trial administrators (full disclosure: I teach a module on psychedelic harms on Clerkenwell Health’s psychedelic facilitator training course).
One aspect of GH Research’s trial is causing concern among the UK psychedelic facilitator community. While Reunion Neuroscience offers its psilocybin-type product to mothers within the context of therapeutic support, GH Research thinks that’s not necessary with 5-meo-DMT. Its pitch deck declares:
We believe that those features and the type of psychoactive effects induced by GH001 [its patented version of 5-meo-DMT] allow for dosing without the need for lengthy and complex patient preparation prior to treatment, with only limited required support from a healthcare provider during the experience and without the need for frequent psychological integration work after the experience. This reduces training requirements for healthcare providers and creates a convenient and efficient potential therapeutic paradigm overall.
Several experienced 5-meo-DMT facilitators in the UK have written to GH Research, Clerkenwell Health, the ethics board for the trial and the Health Research Authority (HRA), to express their concerns. One experienced psychedelic facilitator who has worked on several psychedelic trials (they asked not to be named), wrote to the HRA:
I believe this trial poses significant risks to participants and their children and may not align with ethical standards as outlined by the HRA.
Their concerns are that it’s dangerous for such a powerful psychedelic drug to be given to a vulnerable population - severely-depressed mothers - without much preparation before dosage or therapeutic support after. It threatens the safety of the mother and therefore of their baby as well, they say. One facilitator also questions whether psychedelic-naive mothers could give genuine informed consent for this treatment, especially with limited preparation.
They tell me:
As a participant on the continuous infusion extended DMT trial and on the 5MeO trial at Imperial College , I had experiences that I think would be absolutely terrifying for many people, particularly psychedelic-naive depressed mothers, such as loss of body awareness, the inability to talk, and the feeling that I was dying. I am a very experienced psychonaut and able to cope with this but can you imagine a young mum believing she was dying? This is PTSD territory.
Does the trial adequately warn about the risk of adverse events during or after the experience? The trial description says:
A potential risk associated with administration of psychedelics is the occurrence of acute challenging experiences, which can be characterized by anxiety, panic, or paranoia. The risk of such experiences will be mitigated by patient selection and preparation, and the availability of support during and after the experience.
But preparation before dosage is limited, and support afterwards is apparently limited to a phoneline they can call if they are in difficulties. The trial description continues:
From the literature, some users of this class of drugs have also reported that psychological difficulties, including resurfacing of acute effects, can last for prolonged periods after the experience, referred to as hallucinogen persistent perception disorder. No such lasting psychological difficulties have been described in the GH001 program or in other modern clinical studies with psychedelic agents.
The last part is not true - extended difficulties have been reported in psychedelic clinical trials, including intense suicidal ideation, although they also sometimes haven’t been properly reported; we’ve only heard about them when patients speak up and tell us.
Joel Brierre is the co-founder of F.I.V.E, a 5-meo-DMT harm reduction organisation, as well as founder of Tandava Retreats. He trains 5-meo-DMT facilitators and runs 5-meo-DMT retreats. He is also very worried about GH Research’s trial.
I have huge concerns. 5-meo-DMT can give people a direct experience of the numinous. But even if the experience itself is positive, it can be really destabilizing afterwards, leading to resurfaced trauma or difficult emotions, existential confusion, temporary mania or psychosis, or in worst case scenarios suicide. That’s why we offer a minimum of four weeks of support after sessions. That doesn’t just minimize the risks, it maximizes the potential benefits.
Joel says he reached out to GH Research to offer advice and support in the running of the trial but didn’t hear back. He fears their trial will go the way of Lusaris, a US biotech which raised $60 million to run a 5-meo-DMT trial for depression. It was also offered without therapeutic support. Something went wrong on the trial, and now there is hardly any trace of the company left on the internet.
Both Lusaris and GH Research were backed by RA Capital, a $10 billion private equity fund with a focus on healthcare. RA Capital’s partner and managing director, Adrew Levin, was CEO at Lusaris. I emailed RA Capital to ask if Levin had any comment about what happened to Lusaris or whether GH Research’s post-partum trial was risky. No reply.
More after the paywall…including a video of our great debate between Guy Goodwin of Compass and Max Wolff of Mind Foundation: ‘Must psychedelic treatments include psychotherapy?’
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