• Post-traumatic stress disorder (PTSD) and major depressive disorder do not always respond to therapies or medication.
• In the hunt for effective therapies, the Australian government has authorized the use of psychedelics for these severe mental health issues.
• Under strict controls, Australian psychiatrists will be able to prescribe medicines containing MDMA for severe post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression from July 2023.
• Medical News Today asked experts in the United States and the United Kingdom for their reaction to the decision.

PTSD is a mental health condition that may occur after someone has gone through a traumatic experience. According to the U.S. Department of Veterans Affairs, symptoms — including flashbacks, negative thoughts, and sleep disturbances — can have a major impact on a person’s life.

For some people, PTSD resolves through talking therapies, medication, or both, but for others, treatment is ineffective.

Depression that does not respond adequately to treatment with standard anti-depressants is known as treatment-resistant depression. It is relatively common, occurring in up to 60% of people treated for depression.

Dr. Adrian Jacques H. Ambrose, senior medical director of the Department of Psychiatry at Columbia University Irving Medical Center, told Medical News Today just how important it was to find new treatments.

“According to some studies, a significant portion—approximately half—of the patients with severe psychiatric conditions like PTSD or MDD [major depressive disorder] don’t respond to FDA-approved treatments, like SSRIs,” he noted.

Australian decision

On February 3 this year, the Australian Therapeutic Goods Association (TGA) published its decision to authorize the use of MDMA for PTSD that has not responded to treatment, and psilocybin for treatment-resistant depression from July 2023. Both are substances that are, under any other circumstances, illegal.

“There have been a growing number of studies indicating that these psychedelic compounds — specifically MDMA for PTSD and psilocybin for MDD — may help patients who have severe symptoms and may not have previously responded to traditional treatments.”

– Dr. Adrian Jacques H. Ambrose

The decision has raised some concerns, as Dr. James Rucker, consultant psychiatrist and senior clinical lecturer at King’s College London in the United Kingdom, told MNT.

“Some important caveats apply here,” cautioned Dr. Rucker. “The main one is that the drugs are subjectively noticeable to participants in clinical trials.”

“This means that the placebo response is likely to differ between groups, and this may account for some of the improvement. It is very hard to account for this. The interaction is likely to be complicated. There is promise here, but much uncertainty,” he pointed out.

And Dr. Ambrose also urged caution: “I think it’s a difficult balancing act. On one hand, there’s a lot of real suffering for patients for whom traditional treatments didn’t fully address their psychiatric symptoms. On the other hand, I hope that we — both the scientific community and the patient populations — can temper our zeal and proceed with all the due diligence to ensure that we fully know the risks and benefits of these compounds.”

What are the treatments?

3, 4-methylenedioxy-methamphetamine — the scientific term for MDMA, also known as “ecstasy” — is a synthetic drug that is often used recreationally. Psilocybin is the hallucinogenic substance found in certain mushrooms that grow in Europe, South America, Mexico, and the U.S. — commonly known as “magic mushrooms.”

In authorizing their use in targeted treatments, the TGA stated: “The decision maker recognized there is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions.”

Use of both MDMA and psilocybin is prohibited in Australia, the U.S., and the U.K. Following this decision, medicines containing these substances will be legally used in Australia in strictly controlled medical settings as of July 1, 2023.

Was the decision premature?

The TGA based its decision on evidence from clinical trials, stating that “there is now sufficient evidence that psilocybin and MDMA will potentially be effective in the treatment of treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively, for certain patients. In particular, clinical trials have shown promise when they are used in combination with psychotherapy conducted in strictly controlled medical settings.”

However, Dr. Rucker expressed some misgivings:

“[S]uch decisions short circuit the clinical trials process itself and undermine the whole principle of evidence-based medicine. Where is the motivation to do good quality research into efficacy and safety if a regulator just approves it before such research is complete?”

“From a pharmaceutical company’s perspective, why would they research it if it has already been approved (this is exactly what has happened with medical cannabis)? What message does that send to the field as a whole? This is a slippery slope and a dangerous precedent, I fear,” he told us.

Dr. Ambrose added a note of cautious optimism: “As we continue to expand our research in better understanding the short-term and long-term effects of psychedelics, I hope that we can continue to dialectically hold the balance: the rigorous scrutiny of clinical research and the unifying goals of helping patients with treatment-resistant mental health conditions who are hurting and need effective treatments.”

Benefits and risks

MDMA and psilocybin have known side effects, which Dr. Rucker described:

“Both have their dangers, but within a medically controlled setting these can be minimized. MDMA can cause raised blood pressure and heart rate and, rarely, produce ‘serotonin syndrome,’ which can be dangerous. Psilocybin is quite safe from the perspective of the body, but it can induce panic and paranoia in some people. If this is not managed by skilled psychological support practitioners it can lead to a worsening of someone’s condition.”

Dr. Keith Heinzerling, internist, addiction medicine specialist, and director of the Treatment & Research in Psychedelics Program for the Pacific Neuroscience Institute in Santa Monica, CA, was more optimistic about the use of psilocybin.

“Possible benefits of psilocybin therapy, as opposed to traditional existing treatments, include that treatment may only require a few doses of psilocybin, with counseling and support in between sessions, as opposed to most current medications that are taken daily for the long term,” he told us.

“Also the model of psychedelic therapy is very patient-centered and may help patients to feel more empowered by the treatment,” added Dr. Heinzerling.

He did, however, urge caution: “Patients at high risk of psychoses should not take psilocybin and there are medications — some antidepressants and other medications that affect serotonin — that should not be combined with psilocybin.”

Will other countries follow suit?

The U.S. state of Oregon legalized the therapeutic adult use of psilocybin on January 1, 2023. In Canada, designated physicians can prescribe it for those with severe treatment-resistant depression. In both, the drug is still illegal outside specific therapeutic settings.

There are, as yet, no plans to authorize the use of MDMA or psilocybin in the U.K., but psychiatrists there will be watching the Australian experience closely.

Dr. Trudi Seneviratne, registrar at the Royal College of Psychiatrists, commented: “We are confident that Australian regulators will have ensured the appropriate safeguards are in place for its use and that this will provide important data on the effectiveness of the drug.”

And, as Dr. Ambrose told us, the rest of the world will also be watching:

“I appreciate that [the Australian government has] set up specific restrictions—limiting the prescription to psychiatrists who spent years training to treat psychiatric conditions and having the approval of a human research ethics committee. I think the rest of the world will be looking at the clinical outcomes from the Australian government’s decisions.”

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