Psilocybin Clinical Trials for Depression: 2026 Tracker

Psilocybin Clinical Trials

134 registered trials

ClinicalTrials.gov lists 134 registered psilocybin trials across 54 indications. For depression patients trying to find one to join, the relevant list is much shorter.

Norring & Spigarelli, Drug Des Devel Ther, 2024

3

Phase 3 programs with results or active enrollment as of April 2026

144

patients in EPISODE, the first independent Phase 3-equivalent published RCT (Mertens 2026)

2023

year Australia became the first country to approve psilocybin for TRD nationally

Norring & Spigarelli, Drug Des Devel Ther, 2024

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As of 2024, ClinicalTrials.gov listed 134 registered psilocybin clinical trials spanning 54 different conditions.^[1] That number sounds like enormous momentum. For a person with depression hoping to enroll in a study right now, most of it is noise. The majority of those 134 entries are completed. Many are Phase 1 safety studies in healthy volunteers. A handful are actively recruiting at a limited number of sites, and two of the largest Phase 3 programs closed enrollment after collecting their data in 2025 and early 2026.

This guide cuts through to what matters in 2026: which trials are running, who can actually join them, how the Phase 3 landscape looks after the most recent data releases, and how to find a trial if you are looking for one. For the full evidence picture on what psilocybin does for depression, see our psilocybin for depression clinical evidence guide.

134 Trials, and Why Most Won't Help You Right Now

Norring and Spigarelli combed through every psilocybin entry on ClinicalTrials.gov and found 134 registered trials covering 54 distinct conditions.^[1] Depression and anxiety make up the largest share. The headline of their paper captures the gap starkly: 134 trials, 54 indications, and zero marketing approvals anywhere in the world.

Their analysis found the bottleneck is not evidence quality. It is scheduling infrastructure and regulatory process. Psilocybin is still Schedule I in the United States, which requires a DEA Schedule I researcher license for every site, specialized handling and storage, and extensive IRB oversight. That limits the number of places a trial can run.

For a patient searching for access, this means the practical field in 2026 breaks into four tiers:

1. Phase 3 programs: The two COMPASS trials have completed enrollment and reported results. Usona's uAspire is still recruiting. The German EPISODE trial published results in March 2026.
2. Academic Phase 2 trials: Active studies at Johns Hopkins, NYU, UCSF, the University of Colorado, Imperial College London, and other research centers continue to run follow-on and independent research.
3. Specialized population studies: Separate trials targeting veterans, patients with severe treatment-resistant depression, and other groups are in progress.
4. International access: Australia approved psilocybin therapy nationally in 2023 for treatment-resistant depression, the only country with full regulatory approval.

For background on the legal and regulatory reasons this process has taken so long, see psilocybin's Schedule I history and the path to rescheduling. For the full rundown of Phase 3 trial designs and published data, see Phase III psilocybin trials: what's running right now.

Phase 3 Programs: Two Have Results, Two Are Still in Progress

The Phase 3 picture as of April 2026 has four programs worth tracking. Two are COMPASS Pathways trials that have completed enrollment and issued press releases. One is Usona Institute's actively recruiting study. One published peer-reviewed results in March 2026 from a German team operating independently of any US company.

COMPASS Pathways: COMP005 and COMP006

COMPASS ran two parallel Phase 3 trials of COMP360, its proprietary synthetic psilocybin. COMP005 enrolled 258 participants across 32 sites and tested a single 25mg dose against placebo. Results were announced in June 2025: the primary endpoint, a reduction in MADRS score (a standard depression rating scale) at three weeks, showed a statistically significant difference in favor of psilocybin (MADRS difference of −3.6, p less than 0.001). COMP005 results are from a company press release and have not been peer-reviewed.

COMP006 was larger: 568 participants received either two 25mg doses given three weeks apart or a 1mg active control. Results were announced February 17, 2026. The MADRS difference at six weeks was −3.8 (p less than 0.001); 39% of patients in the psilocybin arm achieved at least a 25% MADRS reduction. Twenty-six-week follow-up data is expected in the second half of 2026. COMP006 results are also press-release only.

COMPASS plans to submit a New Drug Application to the FDA in Q4 2026. Both COMP005 and COMP006 have closed enrollment; these trials are not recruiting.

The 25mg dose used in both trials reflects a body of dose-response evidence. A 2025 network meta-analysis pooled data from 10 randomized controlled trials and 1,022 participants and confirmed that the 25mg dose produced the largest standardized antidepressant effect, outperforming both 10mg and placebo across trial designs.^[6]

Usona Institute: uAspire (PSIL301), Still Enrolling

Usona's Phase 3 trial launched in March 2024 and is still enrolling approximately 240 patients. It tests three arms: 5mg (intended as an active control, expected to produce minimal psychedelic effect), 25mg, and placebo. The critical distinction from COMPASS: uAspire targets major depressive disorder broadly, not just treatment-resistant cases.

Usona's Phase 2 trial, published in JAMA in 2023, enrolled 104 MDD patients who were not required to have failed prior antidepressant treatments. A single 25mg dose produced 36.7% remission at 8 weeks, compared to 22% in the placebo group (odds ratio 2.0, p=0.003).^[4] The uAspire Phase 3 design follows that template. The psychotherapy support in uAspire is intentionally minimal: preparation and integration sessions, but no therapist present during the dosing session itself. This distinguishes it from the COMPASS model, which uses an intensive three-session preparation and structured integration protocol.

If you have moderate-to-severe depression and have not failed multiple prior treatments, uAspire may be worth investigating. The trial is listed on ClinicalTrials.gov and sites can be searched by location.

EPISODE: The Independent Phase 3-Equivalent That Most Competitors Missed

The most significant peer-reviewed development in the psilocybin trial landscape in 2026 is not from COMPASS or Usona. Mertens and colleagues published results from the EPISODE trial in JAMA Psychiatry on March 18, 2026, making it the first fully independent Phase 3-equivalent randomized controlled trial to reach peer review.^[5]

EPISODE enrolled 144 patients with treatment-resistant depression across multiple sites in Germany. The funding came from sources independent of COMPASS and Usona. That independence is scientifically important: when an independent trial run in a different country, under a different regulatory framework, with different investigators, produces consistent results, it strengthens the evidence more than a second trial from the same company.

EPISODE has completed enrollment. It is not currently recruiting. But its March 2026 JAMA Psychiatry publication makes this the first year the Phase 3-level evidence base includes a peer-reviewed, independent trial, not only company announcements.

Cybin CYB003: Phase 3 Expected Second Half of 2026

Cybin is developing CYB003, a deuterated version of psilocybin. The molecular modification is designed to shorten the psychedelic session to approximately four hours, compared to six to eight hours for standard psilocybin. The FDA granted CYB003 Breakthrough Therapy Designation for use as an adjunctive treatment in major depressive disorder in October 2025. Cybin's Phase 3 program, called PARADIGM, is expected to begin enrolling in the second half of 2026. As of April 2026, it is not yet open.

For a detailed comparison of the COMPASS and Usona program architectures, see COMP360 vs. Usona: comparing the two FDA-track psilocybin programs.

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Active Phase 3 program overview, April 2026:

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Academic Center Studies: What's Running Beyond the Pivotal Trials

The most-cited psilocybin depression results came from academic medical centers that continue to run follow-on and independent studies beyond what the Phase 3 programs cover.

Davis and colleagues at Johns Hopkins published the foundational MDD open-label trial in 2021: 24 patients with major depressive disorder, none required to be treatment-resistant, randomized to immediate treatment or a waitlist.^[2] The immediate-treatment group showed 71% response rate and 54% remission at four weeks, compared to 17% response and 0% remission in the waitlist group. The Hopkins team has continued research since, including studies in additional populations and designs.

Carhart-Harris and colleagues at Imperial College London published the escitalopram comparison in the New England Journal of Medicine in 2021: 59 patients randomized to psilocybin versus six weeks of escitalopram showed comparable primary-endpoint scores, but the psilocybin group had significantly better secondary outcomes in emotional well-being, sense of meaning, and anhedonia.^[3] Imperial's Centre for Psychedelic Research has continued Phase 2 studies since.

A 2024 randomized controlled trial from a Canadian academic group tested whether two doses work better than one.^[7] Rosenblat and colleagues enrolled 30 treatment-resistant patients and gave them a 3mg priming dose followed by 25mg three weeks later. The two-dose sequence produced significant MADRS reductions with response sustained at six weeks. Ongoing Phase 2 research is still working through questions about dosing sequence, session length, and therapy model that Phase 3 designs cannot address because they are locked to a single protocol.

Academic sites with confirmed psilocybin depression research programs as of 2026 include:

• Johns Hopkins Center for Psychedelic and Consciousness Research (Baltimore, MD)
• NYU Langone Health Psychedelic Research Program (New York, NY)
• UCSF Neuroscape Psychedelics Division (San Francisco, CA)
• University of Colorado Center for Psychedelic Research (Boulder, CO)
• Imperial College London Centre for Psychedelic Research (London, UK)
• Amsterdam UMC (the Netherlands)

For a comprehensive look at what all the major published trials have found, including effect size numbers and methodology, see every major psilocybin depression trial: a complete guide.

You Don't Need Treatment-Resistant Depression to Qualify for Every Trial

The COMPASS Phase 3 trials enrolled only patients with treatment-resistant depression, typically defined as failing two adequate antidepressant courses. That restriction has created a widespread misconception: that psilocybin trials are only for the most severely ill patients who have run out of other options.

Usona's program was built on a different premise from the start. The 2023 JAMA trial enrolled 104 MDD patients with no requirement to have failed prior treatments.^[4] A single 25mg dose produced 36.7% remission at 8 weeks versus 22% in the placebo group. The uAspire Phase 3 follows the same broader inclusion criteria.

A 2024 meta-analysis published in Lancet Psychiatry that analyzed psychedelic therapy trials across multiple conditions found significant effects on depression and anxiety symptoms in populations that were not restricted to TRD.^[12] The evidence base is not confined to the most treatment-refractory patients.

For anyone earlier in the treatment process, someone with moderate-to-severe depression who has tried one or two antidepressants but not six, Usona's uAspire and several ongoing academic Phase 2 trials may be available options. Eligibility criteria are listed in full on each trial's ClinicalTrials.gov page.

Specialized Population Trials: Veterans and the Most Severely Ill

Two recent trials specifically addressed populations that standard clinical research has historically excluded.

Ellis and colleagues published the first psilocybin trial conducted specifically in U.S. military veterans with severe treatment-resistant depression in 2025.^[9] The pilot enrolled 15 veterans and tested the feasibility of psilocybin therapy in this population. Results showed the protocol was feasible and produced meaningful antidepressant effects. No comparable study in this population had existed before this publication.

Aaronson and colleagues published a 2025 open-label trial in the American Journal of Psychiatry targeting patients at the opposite extreme of treatment resistance: 25 people who had failed at least six prior treatments.^[8] In this group, a single psilocybin dose produced a 60% response rate and 53% remission at three weeks. For context: in most antidepressant trials, patients at this severity level rarely reach even 20% remission. Both of these studies are complete and not currently recruiting, but they demonstrate that the trial ecosystem is expanding to populations that the pivotal programs cannot reach.

How to Find Active Psilocybin Clinical Trials in 2026

The single most reliable resource is ClinicalTrials.gov. Here is a practical sequence for a patient looking to enroll:

1. Search ClinicalTrials.gov for "psilocybin" and filter by condition (depression, major depressive disorder, or treatment-resistant depression) and recruitment status (recruiting). This returns all currently enrolling US studies.

2. Look for Usona's uAspire study by name under PSIL301 or by searching "Usona psilocybin depression." The trial is geographically distributed across multiple sites; check the site list to find locations.

3. Contact academic centers directly. Johns Hopkins, NYU Langone, UCSF, and the University of Colorado all maintain patient interest lists. Joining these lists provides earlier notification of trial openings than waiting for ClinicalTrials.gov updates.

4. Ask about expanded access. Patients with treatment-resistant depression who have exhausted available treatments may be eligible for FDA-regulated expanded access (also called compassionate use) programs outside of a formal trial. For a complete explanation of how this works, see expanded access programs for psilocybin: how they work.

5. Check patient advocacy registries. MAPS, the Usona Institute's patient portal, and COMPASS's patient registry collect interest from potential participants and may notify you when trials open at sites near you.

If no US option is geographically or medically feasible, see legal psilocybin access before FDA approval: all current options for the full range of alternatives, including state-level programs in Oregon and Colorado and international options.

The Safety Baseline Before You Decide to Enroll

Patients considering trial participation are often most concerned about what the experience actually involves and what can go wrong.

Lancelot and colleagues published a 2024 meta-analysis examining acute adverse events across all published therapeutic-dose psilocybin trials.^[10] The most common events were headache, nausea, and anxiety, all rated mild to moderate in severity. The large majority resolved within 24 hours of the session. Serious adverse events were rare. Cardiovascular events, including blood pressure elevation, were not significantly elevated compared to placebo, a concern that had been raised in early Phase 1 work.

The trial setting mitigates these risks through structure. Participants in every published depression trial receive preparation sessions before the dosing day, continuous monitoring by trained staff throughout a six-to-eight-hour session, and integration sessions afterward. The psychological challenge of the session is anticipated and managed within the protocol, not treated as a side effect.

What this safety record reflects is trial populations with strict screening. People with personal or family history of psychosis, certain cardiac conditions, or active suicidal ideation with intent are excluded from enrollment. Results from screened and monitored trial populations may not describe what happens in uncontrolled settings.

International Option: Australia Approved Psilocybin Nationally in 2023

Australia's Therapeutic Goods Administration approved psilocybin as a prescription medicine for treatment-resistant depression in 2023, making Australia the first country in the world to do so through its national regulatory body.

Dutton and colleagues published a 2026 review in the Australian and New Zealand Journal of Psychiatry documenting the first year of clinical rollout in practice.^[11] The picture is mixed. The approval created a legal pathway, but implementation has faced real constraints: the psychiatrists authorized to prescribe psilocybin require specialized training that few have completed, the six-to-eight-hour monitored sessions require purpose-built clinical spaces that most practices do not have, and consent procedures are complex. Access is not uniformly available across the country.

For patients outside the US or those willing to consider international travel, Australia represents the only jurisdiction where psilocybin therapy for TRD is a regulated clinical option outside of a trial. Patients interested in this pathway should research current availability of authorized psychiatrists and factor in wait times and costs, which are not covered by standard insurance.

What the February 2026 FDA Block Means for Trial Participants

On February 4, 2026, the Trump administration blocked the FDA's plan to expedite its review of the upcoming COMPASS NDA. This was a regulatory process intervention, not a finding about safety or efficacy.

For people currently enrolled in a US clinical trial, the block has no direct effect. Existing trials continue under the approvals under which they were authorized. No ongoing study has been suspended or modified. The February action affects the timeline and procedural pathway for COMPASS's approval application, not the science being conducted at research sites.

The broader context of FDA approval status, Breakthrough Therapy Designations, and what the political environment means for the approval timeline is covered in psilocybin's path to FDA approval for depression: where things stand.

The Bottom Line

As of April 2026, the psilocybin clinical trial landscape for depression includes two completed COMPASS Phase 3 programs with positive press-release results (COMP005 and COMP006, NDA expected Q4 2026), one actively recruiting Phase 3 study open to broader MDD patients (Usona's uAspire), and the first independently peer-reviewed Phase 3-equivalent trial (EPISODE, JAMA Psychiatry, March 2026). Academic Phase 2 trials continue at major research centers. Australia remains the only country with full national regulatory approval. The February 2026 FDA political intervention affects approval timing but has no impact on ongoing research participation.

Frequently Asked Questions

How can I participate in a psilocybin clinical trial for depression?

Search ClinicalTrials.gov for "psilocybin depression" and filter by recruiting status. Contact academic centers including Johns Hopkins, NYU Langone, UCSF, and the University of Colorado, which maintain patient interest lists for upcoming studies. Usona's uAspire Phase 3 trial (PSIL301) is actively recruiting approximately 240 MDD patients as of 2026. Expanded access programs are also available for eligible treatment-resistant patients through some sponsors.

Are there psilocybin trials near me in 2026?

Trial site locations are listed under each study's "Contacts and Locations" tab on ClinicalTrials.gov. Major active sites in the US include Johns Hopkins (Baltimore), NYU Langone (New York), UCSF (San Francisco), and the University of Colorado (Boulder). COMPASS's COMP005 and COMP006 ran across 32 sites in multiple countries but have closed enrollment. Registering with academic center mailing lists is the most reliable way to be notified when new sites open.

Are psilocybin trials open to people without treatment-resistant depression?

Yes. Usona's uAspire Phase 3 trial targets MDD broadly, not only patients who have failed multiple antidepressants. Raison et al. (JAMA, 2023) found 36.7% remission at 8 weeks in 104 MDD patients with no prior-treatment failure requirement; that Phase 2 result forms the basis for the Phase 3 design. Many academic Phase 2 trials also enroll patients with moderate-to-severe MDD who have not exhausted prior treatments. Each trial's specific eligibility criteria are on ClinicalTrials.gov.

What is the difference between psilocybin Phase 2 and Phase 3 trials?

Phase 2 trials test safety and preliminary efficacy in a small-to-medium group (typically 20 to 200 patients) to find the right dose and confirm that the drug produces the expected effect. Phase 3 trials are larger (100 to 600 or more patients), multi-site, randomized, and placebo-controlled, designed to produce the full evidence package required for an FDA drug approval application. Phase 3 results have higher regulatory weight; Phase 2 trials continue to run alongside Phase 3 programs because they can test dosing variations and populations that the pivotal designs cannot.

What conditions are being studied with psilocybin in 2026?

Norring and Spigarelli (2024) identified 134 registered psilocybin trials covering 54 indications. Depression and anxiety are the most common. Others include PTSD, alcohol use disorder, OCD, anorexia nervosa, end-of-life distress in cancer patients, and cluster headaches. Most active Phase 3 enrollment as of 2026 is in depression. A 2024 Lancet Psychiatry meta-analysis found significant efficacy signals across depression, anxiety, and PTSD conditions in psychedelic therapy trials.

How much do psilocybin trial participants get paid?

Compensation varies by trial. Most academic studies provide modest stipends covering transportation and time, typically in the range of $25 to $75 per visit, with multi-session trials sometimes totaling $200 to $400 in total compensation. Compensation amounts are set by each institution's IRB to avoid constituting undue financial inducement for participation. Specific figures are listed in each trial's ClinicalTrials.gov record under the "More Information" section.

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