Psychedelic-assisted therapy
An active area of research, with promising results for some conditions and many questions still unanswered. It requires medical assessment, rigorous protocols and specialist clinical oversight.
The field of research
Substances such as psilocybin and MDMA are being studied in clinical settings, usually within protocols that include psychological preparation and support. Among the most researched areas are treatment-resistant depression, post-traumatic stress disorder and some addictions.1,2
Results have been encouraging in some studies, but the evidence is still evolving. Important questions remain about who may benefit, for how long and with what risks.
What is approved
In the European Union, intranasal esketamine is approved for treatment-resistant depression and is administered in a clinical setting under supervision, in combination with antidepressant treatment.3
Psilocybin and MDMA are not approved as medicines in the European Union. In Portugal, their therapeutic use takes place only in clinical research.
Some countries have created restricted access pathways. In Australia, since July 2023, authorised psychiatrists can prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.4 In the Czech Republic, since January 2026, psilocybin can be prescribed by psychiatrists under conditions defined by law.5
Why clinical context and oversight matter
In these treatments, the substance is only one part of the process. Prior assessment, preparation, the context of the session and subsequent follow-up help reduce risks and determine whether this approach makes sense for each person.
Use outside a clinical context should not be confused with medical treatment and may involve significant risks. Pedro Zuzarte has written about this in «Psychedelics in mental health: balancing promise with prudence».
Safety
There are situations in which these treatments require particular caution or may not be recommended, such as a history of psychosis, some cases of bipolar disorder, uncontrolled cardiovascular disease or drug interactions. The decision must be individual and based on a full psychiatric assessment.
Pedro Zuzarte and this field
- Training in psychedelic-assisted therapies from the California Institute of Integral Studies (CIIS).
- Training in MDMA-assisted therapy from MAPS.
- In 2022 he created the psychedelic-assisted therapy programme at the Centro Clínico das Janelas Verdes.
- Director of the programme «Introduction to Psychedelic Therapy: Research and Clinical Practice» at the Faculty of Medicine of the University of Lisbon.
- Director of KETAMED Portugal.
His first contact with clinical research on psychedelics was in 2006, during an internship at the Federal University of Santa Catarina, Brazil. In 2023 and 2024 he completed the CIIS postgraduate certificate in psychedelic-assisted therapies and the MDMA-assisted therapy training of the Multidisciplinary Association for Psychedelic Studies (MAPS).
The Faculty of Medicine programme brings together national and international faculty and brings research and clinical practice in this field into medical education.
Information on treatments
This page is for information only. Information on treatments, assessment and how they work is available from KETAMED Portugal, dedicated to psychedelic-assisted therapy.
References
- Goodwin GM, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. N Engl J Med. 2022;387(18):1637–1648.
- Mitchell JM, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27(6):1025–1033.
- European Medicines Agency. Register of medicines authorised in the European Union: intranasal medicine for treatment-resistant depression (authorised in 2019).
- Therapeutic Goods Administration (Australia). Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists. 2023.
- Czech Republic. Amendment to the Medicines Act allowing psilocybin to be prescribed for therapeutic use, in force since 1 January 2026.
The first step is a psychiatric assessment to determine suitability and clarify the options.