Psychedelics: Who wants them used for which mental-health conditions?
Updated 5 October 2026
Therapeutic Goods Administration · Treatment-resistant depression
Australia classifies psilocybine for treatment-resistant depression as Schedule 8 for this purpose, allowing specifically authorised psychiatrists to use unapproved products outside clinical trials under HREC and TGA oversight.
Therapeutic Goods Administration · Major depressive disorder
The TGA's current access pathway is limited to psilocybine for TRD and MDMA for PTSD. For all other indications, including broader MDD, those substances remain Schedule 9 and are limited to medical or scientific research. This is a drug-specific regulatory position, not a judgment about every psychedelic.
Therapeutic Goods Administration · Post-traumatic stress disorder
Australia classifies MDMA for PTSD as Schedule 8 for this purpose, allowing specifically authorised psychiatrists to use unapproved products outside clinical trials under HREC and TGA oversight.
Therapeutic Goods Administration · Generalized anxiety disorder
The TGA limits outside-trial access to psilocybine for TRD and MDMA for PTSD. For GAD, MDMA and psilocybine remain Schedule 9 and are limited to research. This does not address every psychedelic compound.
Therapeutic Goods Administration · Substance-use disorders
The TGA limits outside-trial access to psilocybine for TRD and MDMA for PTSD. For substance-use disorders, MDMA and psilocybine remain Schedule 9 and are limited to research. This does not address every psychedelic compound.
Royal College of Psychiatrists · Treatment-resistant depression
RCPsych says current evidence does not support routine clinical use of psychedelic and related substances and calls for further high-quality research, explicitly including depression that is less responsive to other care. The source does not separately state a position on tightly regulated exceptional access outside trials, so the broader access proposition remains unclear.
Royal College of Psychiatrists · Major depressive disorder
RCPsych identifies depression as a condition with promising early studies but says there is not enough high-quality evidence for routine clinical use. It does not specify whether any regulated non-routine access for broad MDD should be permitted.
Royal College of Psychiatrists · Post-traumatic stress disorder
RCPsych names PTSD among conditions with potential benefit but concludes that evidence is not yet strong enough for routine clinical use. It does not resolve the narrower question of exceptional regulated access outside trials.
Royal College of Psychiatrists · Generalized anxiety disorder
RCPsych cites anxiety disorders among areas of early promise but does not isolate generalized anxiety disorder. Its overall position is that evidence does not yet support routine clinical use, leaving the exact GAD access proposition unclear.
Royal College of Psychiatrists · Substance-use disorders
RCPsych includes substance misuse among areas with initial promising studies but says high-quality evidence is insufficient for routine clinical use. It does not set out a specific regulated-access position for substance-use disorders.
Compass Pathways · Treatment-resistant depression
Compass has entered a rolling NDA process for COMP360 in treatment-resistant depression and is preparing for post-approval delivery if the FDA approves it. The status applies specifically to COMP360, not to psychedelics as a class.
Compass Pathways · Post-traumatic stress disorder
The FDA accepted Compass's IND for a late-stage COMP360 PTSD trial, but the company's July 2026 expanded-access policy says expanded access is not appropriate for PTSD while safety and efficacy still need controlled study conditions. This is an active development path, not current support for clinical access outside research.
Definium Therapeutics · Major depressive disorder
Definium reported positive Phase 3 MDD results and says it is advancing toward FDA submission for DT120, a pharmaceutical formulation of lysergide/LSD. The status applies to DT120 and broad MDD, not specifically to TRD.
Definium Therapeutics · Post-traumatic stress disorder
Definium says its Phase 3 Haven study in PTSD is expected to start in 2027. That is a clear development commitment but not yet a request for approval or a position supporting outside-trial clinical access.
Definium Therapeutics · Generalized anxiety disorder
Definium reported a second positive Phase 3 GAD trial in September 2026 and says a pre-NDA meeting is scheduled for Q4 2026 with an NDA filing anticipated in the first half of 2027. The status applies specifically to DT120.
Usona Institute · Major depressive disorder
Usona launched the uAspire Phase 3 program to evaluate psilocybin for adults with MDD and describes it as a potential new treatment. The dated institutional source documents research development rather than a current position for clinical access outside trials, so it is coded qualified.
Multidisciplinary Association for Psychedelic Studies · Post-traumatic stress disorder
MAPS welcomed renewed FDA evaluation of the MDMA-assisted therapy NDA, defended the underlying research program it initiated and funded, and continues to focus on how people affected by trauma can access treatments made possible by that research. MAPS no longer has an active role in the current commercial drug-development program.
TheraPsil · Treatment-resistant depression
TheraPsil's open letter calls for medical psilocybin to be accessible on compassionate grounds to Canadians with treatment-resistant physical and mental health conditions, explicitly including depression among the examples.
TheraPsil · Major depressive disorder
TheraPsil's open letter names depression while framing access around treatment-resistant conditions. That supports a depression-access stance but is not precise enough to code support for broad MDD beyond TRD.
TheraPsil · Post-traumatic stress disorder
After Manitoba's first Special Access Program approval for MDMA-assisted therapy, developed with TheraPsil, the organization explicitly said Canadians deserve regulated access and described the treatment as a real clinical option; the clinic initially focuses on chronic PTSD.
TheraPsil · Generalized anxiety disorder
TheraPsil's open letter includes anxiety among conditions for which it seeks compassionate psilocybin access, but it does not identify generalized anxiety disorder as the specific diagnosis.
TheraPsil · Substance-use disorders
TheraPsil's open letter explicitly includes severe substance-use disorder in its call for compassionate medical psilocybin access, and Project Solace later sought provincial funding for psilocybin-assisted psychotherapy while highlighting a patient with substance-use disorder.
Heroic Hearts Project · Post-traumatic stress disorder
Heroic Hearts Project says it helps veterans access structured psychedelic programs for service-related trauma and advances federal advocacy for legal, regulated psychedelic therapies in U.S. healthcare. Its 2026 statement specifically centers PTSD and related veteran conditions.
Psychedelic Access and Research European Alliance · Post-traumatic stress disorder
PAREA co-organised a 2026 European Parliament discussion on psychedelic research and access for war-related trauma and PTSD. The resulting statement called for controlled research frameworks and high-quality trials, so the current position is research-and-access oriented rather than support for immediate clinical use outside trials.
Sources
- Therapeutic Goods Administration — Accessing MDMA (3,4-methylenedioxy-methamphetamine) and psilocybine as a psychiatrist ·
- Royal College of Psychiatrists — More research needed into psychedelics as potential treatments for mental disorders, calls RCPsych ·
- Compass Pathways — Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher ·
- Compass Pathways — Compass Pathways’ New 52-Week Topline Open-Label Data from Phase 3 COMP005 Trial Demonstrates Additional Benefit from Another COMP360 Dose in Part C Extending Durability Out to 1 Year ·
- Compass Pathways — Compass Pathways Announces FDA Acceptance of IND Application for PTSD and Hosts Webinar on PTSD and TRD ·
- Compass Pathways — Expanded Access Policy ·
- Definium Therapeutics — Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder ·
- Definium Therapeutics — Definium Therapeutics Announces Positive Topline Results from Phase 3 Panorama Study of DT120 ODT in Generalized Anxiety Disorder ·
- Definium Therapeutics — Definium Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights ·
- Usona Institute — Usona Statement on Phase 3 Study of Psilocybin for Major Depressive Disorder (MDD) (uAspire) ·
- Multidisciplinary Association for Psychedelic Studies — MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA ·
- TheraPsil — TheraPsil's Open Letter to Canada's Health Ministers ·
- TheraPsil — Project Solace Launches Campaign for Psilocybin Funding: Second Letter to Minister Jennifer Whiteside ·
- TheraPsil — First MDMA-Assisted Therapy for PTSD Approved in Manitoba ·
- Heroic Hearts Project — Heroic Hearts Project and Healing Breakthrough Applaud Introduction of the Veterans Health Administration Novel Therapeutics Preparedness Act ·
- Psychedelic Access and Research European Alliance — Psychedelic research and access in Ukraine: advancing evidence-based responses to war-related mental health needs ·
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