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Scientific evidence

This page summarises what studies show about psychedelic therapy: what is under research, what has positive results and what is already approved, and where. Studied is not the same as approved, and approved in another country is not the same as available in Portugal.

State of research and clinical practice

Under investigation

Substances studied in clinical trials, without definitive conclusions.

Other potential clinical applications

Positive results, still experimental

Positive results in controlled trials, but no authorisation as a medicine in the European Union.

  • Psilocybin in treatment-resistant depressionPhase 2b published; two positive phase 3 trials according to the sponsor, not yet published in peer-reviewed form [1] [8] [9]
  • LSD in generalised anxiety disorderPhase 2b published in 2025; positive phase 3 trials according to the sponsor, not yet peer-reviewed [10] [11]
  • MDMA in post-traumatic stress disorderTwo positive phase 3 trials; not approved by the US Food and Drug Administration (FDA) in 2024 [12] [13]

Approved, and where

Actual authorisations, always with jurisdiction and indication.

  • Dissociative anaesthetic as a nasal formulation, European UnionOne enantiomer, as a nasal formulation: treatment-resistant depression in adults, with an antidepressant, under supervision (European Medicines Agency, EMA, 2019) [14]
  • The same formulation, USATreatment-resistant depression (FDA, 2019); monotherapy added to the US label in 2025 [15] [16]
  • Psilocybin and MDMA, AustraliaPrescription by authorised psychiatrists, controlled scheme (Therapeutic Goods Administration, TGA, 2023) [17]

Ketamine and esketamine: what is authorised

Clinical framework at KETAMED

Not a category of evidence: this is how the clinic works, within the Portuguese legal framework.

  • Individual assessmentAssessment consultation, with psychiatric and physical-health assessment
  • Individual planAgreed with you after the assessment, under medical and nursing supervision

How care works

Other potential clinical applications

Areas where research is exploring new therapeutic possibilities. They are not approved indications, and the suitability of any approach depends on individual clinical assessment.

  • Obsessive-compulsive disorderPsilocybin

    Studied for reducing persistent obsessive and compulsive symptoms, with favourable early results that still need confirmation [18] [19].

  • Smoking cessationPsilocybin with cognitive behavioural therapy

    Studied as support to stop smoking, with more abstinence at six months than with the nicotine patch, in an open-label randomised pilot trial (82 participants) [20].

  • Anorexia nervosaPsilocybin

    Researched mainly for safety and acceptability, in a disorder with few treatment options [21].

  • Trauma and couple relationshipsMDMA

    Studied in conjoint psychotherapy when one partner has post-traumatic stress disorder, in a small uncontrolled trial (six couples) [22]. An exploratory area, not an established indication.

  • Social anxiety in autistic adultsMDMA

    Studied for reducing social anxiety, combined with psychotherapy. The research concerns social anxiety, not autism [23].

  • Alcohol use disorderMDMA

    Studied for safety and tolerability after detoxification, alongside psilocybin research in this area [24].

Explore the substances

The ‘Breakthrough Therapy’ designation

It is a designation from the US medicines agency (FDA) that recognises the potential of an investigational product for a specific indication, when preliminary data suggest a meaningful improvement over existing options. It can speed up development and review, but it is not an approval [25].

It has not been granted to the psychedelic field as a whole: it applies to specific programmes, such as psilocybin formulations for depression and MDMA with psychotherapy for post-traumatic stress disorder, which was not approved in 2024 [13].

On the difference between research, authorisation and access in other countries, see also Australia and Oregon: two models of access and Law and the limits of clinical access.

This information is educational and the sources are verified. It does not constitute a treatment recommendation or advertising of medicines.

References

25
  1. Goodwin GM, Aaronson ST, Alvarez O, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. N Engl J Med. 2022;387:1637–1648. doi:10.1056/NEJMoa2206443Clinical trial
  2. Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181–1197. doi:10.1177/0269881116675513Clinical trial
  3. Bogenschutz MP, Ross S, Bhatt S, et al. Percentage of heavy drinking days following psilocybin-assisted psychotherapy vs placebo in the treatment of adult patients with alcohol use disorder: a randomized clinical trial. JAMA Psychiatry. 2022;79(10):953–962. doi:10.1001/jamapsychiatry.2022.2096Clinical trial
  4. Holze F, Gasser P, Müller F, Dolder PC, Liechti ME. Lysergic acid diethylamide-assisted therapy in patients with anxiety with and without a life-threatening illness: a randomized, double-blind, placebo-controlled phase II study. Biol Psychiatry. 2023;93(3):215–223. doi:10.1016/j.biopsych.2022.08.025Clinical trial
  5. Palhano-Fontes F, Barreto D, Onias H, et al. Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial. Psychol Med. 2019;49(4):655–663. doi:10.1017/S0033291718001356Clinical trial
  6. Erritzoe D, Barba T, Benway T, et al. A short-acting psychedelic intervention for major depressive disorder: a phase IIa randomized placebo-controlled trial. Nat Med. 2026;32:591–598. doi:10.1038/s41591-025-04154-zClinical trial
  7. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27:1025–1033. doi:10.1038/s41591-021-01336-3Clinical trial
  8. Compass Pathways. Company announcement, 23 June 2025: first phase 3 trial (COMP005, n = 258) of COMP360 psilocybin in treatment-resistant depression met its primary endpoint (MADRS difference versus placebo at week 6: −3.6). Topline data, not peer reviewed. ir.compasspathways.comSponsor announcement, not peer reviewed
  9. Compass Pathways. Company announcement, 17 February 2026: second phase 3 trial (COMP006, n = 581) met its primary endpoint (25 mg versus 1 mg, MADRS difference at week 6: −3.8). Topline data, not peer reviewed. ir.compasspathways.comSponsor announcement, not peer reviewed
  10. Robison R, Barrow R, Conant C, et al. Single treatment with MM120 (lysergide) in generalized anxiety disorder: a randomized clinical trial. JAMA. 2025;334(15):1358–1372. doi:10.1001/jama.2025.13481Clinical trial
  11. Definium Therapeutics. Topline results of the phase 3 Panorama study of DT120 in generalised anxiety disorder, 14 September 2026: placebo-adjusted HAM-A change of 5.1 points at week 12; the company also reported a positive phase 3 study (Emerge) in major depressive disorder in June 2026 (SEC Form 8-K, exhibit 99.1). Not peer reviewed. sec.govSponsor announcement, not peer reviewed
  12. Mitchell JM, Ot’alora G M, van der Kolk B, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023;29:2473–2480. doi:10.1038/s41591-023-02565-4Clinical trial
  13. U.S. Food and Drug Administration. Psychopharmacologic Drugs Advisory Committee meeting on midomafetamine (MDMA) capsules for PTSD, 4 June 2024; the FDA subsequently issued a Complete Response Letter (August 2024) requesting an additional phase 3 trial. fda.govRegulatory source
  14. European Medicines Agency. European public assessment report (EPAR) and product information for esketamine nasal spray; marketing authorisation in the EU since 18 December 2019. ema.europa.euRegulatory source
  15. U.S. Food and Drug Administration. Drugs@FDA: esketamine nasal spray, New Drug Application 211243 (approved March 2019; distribution restricted to certified healthcare settings). accessdata.fda.govRegulatory source
  16. U.S. Food and Drug Administration. Esketamine nasal spray, US prescribing information revised January 2025: adds use as monotherapy for treatment-resistant depression in adults. US labelling does not change EU or Portuguese indications. accessdata.fda.govRegulatory source
  17. Therapeutic Goods Administration (Australia). Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists (effective 1 July 2023). tga.gov.auRegulatory source
  18. Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006;67(11):1735–1740. doi:10.4088/jcp.v67n1110Clinical trial
  19. Moreno FA, Allen KE, Wiegand CB, et al. A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive-compulsive disorder. J Psychopharmacol. 2026;40(5):837–849. doi:10.1177/02698811261424214Clinical trial
  20. Johnson MW, Naudé GP, Hendricks PS, Garcia-Romeu A. Psilocybin or nicotine patch for smoking cessation: a pilot randomized clinical trial. JAMA Netw Open. 2026;9(3):e260972. doi:10.1001/jamanetworkopen.2026.0972Clinical trial
  21. Peck SK, Shao S, Gruen T, et al. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Nat Med. 2023;29(8):1947–1953. doi:10.1038/s41591-023-02455-9Clinical trial
  22. Monson CM, Wagner AC, Mithoefer AT, et al. MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Eur J Psychotraumatol. 2020;11(1):1840123. doi:10.1080/20008198.2020.1840123Clinical trial
  23. Danforth AL, Grob CS, Struble C, et al. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018;235(11):3137–3148. doi:10.1007/s00213-018-5010-9Clinical trial
  24. Sessa B, Higbed L, O’Brien S, et al. First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. J Psychopharmacol. 2021;35(4):375–383. doi:10.1177/0269881121991792Clinical trial
  25. U.S. Food and Drug Administration. Breakthrough Therapy designation: definition and criteria (designation applies to a specific investigational product for a specific indication). fda.govRegulatory source

Frequently asked questions

What is the difference between researched, experimental and approved?

Researched means there are clinical trials under way or published. Experimental means there are positive results in controlled trials, but no authorisation as a medicine yet. Approved means an actual authorisation, always for a specific indication and jurisdiction.

Does the “Breakthrough Therapy” designation mean a treatment is approved?

No. It is a designation from the US Food and Drug Administration (FDA) that can speed up the development of an investigational product for a specific indication, but it is not approval.

Does approved in another country mean available in Portugal?

No. Each authorisation applies to the jurisdiction that grants it. For example, prescribing of psilocybin and MDMA by authorised psychiatrists in Australia, since 2023, has no effect in Portugal.

Content reviewed by the KETAMED® clinical team, under medical direction, on .

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