Since 01/07/2023, authorised psychiatrists can prescribe MDMA for PTSD and psilocybin for treatment-resistant depression. Neither is an approved product, uptake is still small, and a course of treatment is costly and loosely defined. This lesson prepares learners for the first request before it arrives.
1. Treatment overview
- MDMA is an entactogen. It increases serotonin, noradrenaline and dopamine, and is intended to reduce fear when recalling trauma so patients can engage more deeply in psychotherapy.
- Psilocybin occurs naturally in more than 100 mushroom species. Its active form, psilocin, acts on serotonin 5-HT2A receptors and alters perception, emotion and sense of time.
- Neither drug treats the condition on its own. Both are used as part of psychedelic-assisted psychotherapy, with preparation and integration sessions.
2. Current literature and evidence
- MDMA for PTSD: in the Phase 3 MAPP1 trial, 67% of the MDMA group no longer met PTSD criteria after treatment, versus 32% on placebo. Phase 2 follow-up suggested benefit lasting at least 12 months in many patients. Some participants later accessed recreational MDMA.
- In August 2024 the US FDA declined to approve MDMA-assisted therapy for PTSD, citing concerns about trial integrity and blinding, and asked for a further Phase 3 trial.
- Psilocybin for treatment-resistant depression: in a 233-patient Phase 2 trial, a single 25 mg dose gave a 37% response at 3 weeks, falling to 20% at 12 weeks. Worsening suicidal ideation occurred in 14% of the 25 mg group.
- Compass Pathways' COMP360 psilocybin Phase 3 trials have since reported. COMP005 (258 patients, 2025) and COMP006 (581 patients, 2026) both met their primary endpoint, with modest average improvements in depression scores over the comparator at 6 weeks. The 233-patient Phase 2 trial is no longer the largest. COMP360 is not approved in Australia.
- A head-to-head trial found no statistically significant difference between psilocybin and escitalopram at 6 weeks.
- MDMA trials are small, blinding is hard (participants usually know if they received the drug), and patients are highly selected. Colleges describe the field as in its infancy.
3. Prescribing guidelines and regulation
- MDMA (for PTSD) and psilocybin (for treatment-resistant depression) moved from Schedule 9 to Schedule 8 for those uses only. There is still no MDMA or psilocybin product on the ARTG.
- Only psychiatrists approved as Authorised Prescribers can prescribe. They need RANZCP fellowship, ethics committee (HREC) approval, specific training and evidence-based protocols. They must obtain informed consent, report adverse events, and report patient numbers to the TGA every 6 months.
- Uptake is small: 63 psychiatrists approved for MDMA and 60 for psilocybin between 01/07/2023 and 31/07/2026 (TGA FOI data).
- The TGA expects approved treatments to be tried first, but does not define how many must fail. RACGP and RANZCP both stress limited, uncertain benefit and the need for close psychiatric oversight.
4. Indications and contraindications
- Indications: MDMA for PTSD only; psilocybin for treatment-resistant depression only. Other uses remain illegal outside trials.
- MDMA contraindications include epilepsy, heart arrhythmia or very high blood pressure, liver disease, susceptibility to hyponatraemia or hyperthermia, history of schizophrenia, bipolar disorder or psychotic features, and current MAOIs.
- Psilocybin contraindications include schizophrenia, bipolar disorder or psychotic features, borderline personality disorder, active suicidal ideation, arrhythmia or very high blood pressure, epilepsy, cerebrovascular disease, pregnancy and breastfeeding.
- Interactions: most antidepressants and psychotropics act on serotonin. Combined use may blunt or heighten effects and carries a serotonin toxicity risk, so a supervised washout is usually needed. MDMA is metabolised by CYP2D6, and about 10% of people metabolise it poorly.
5. Processes
- A course is not standardised. Trials used up to 3 dosing sessions about 4 weeks apart, each lasting 6 to 8 hours with two therapists present, plus preparation and integration psychotherapy.
- IMM's 2023 estimate was $15,000 to $20,000 per course. It is privately funded, not PBS.
- Antidepressant washout before treatment is itself a risk period: withdrawal symptoms and depressive relapse can occur.
6. What it means for you
| Role | What to do |
|---|---|
| Case manager or IMA | Confirm Authorised Prescriber status, the diagnosis, which approved treatments have failed, the full protocol (sessions, therapists, integration), total cost, outcome measures and the plan if it doesn't work. Get a pharmacist review of the washout and interactions. Clarify liability for adverse effects of an unapproved treatment before funding. |
| Rehab provider | Plan around dosing days and integration sessions. Expect short-term fluctuation. Monitor mood and suicidal ideation, especially during washout and after dosing. |
| WHS officer | No driving or safety-critical work on dosing days, and until cleared afterwards. MDMA can appear on amphetamine-class drug screens, so connect declarations to testing. |