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Magic mushroom compound tested for Long-Term depression relief

NCT ID NCT06605105

Disease control Sponsor: Cybin IRL Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study is a long-term follow-up for people with major depressive disorder who already completed a previous trial with CYB003, a drug similar to psilocybin. It will test how safe and effective CYB003 is over time, with optional extra doses. About 468 participants will be monitored using a standard depression rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CYB003 (a deuterated psilocin analog, similar to the active compound in magic mushrooms)
What this could lead to
If successful, this could provide a new, long-term treatment option for people with major depressive disorder that may reduce symptoms with fewer doses than current antidepressants.
What could go wrong
This is an extension study, so participants already responded well in earlier trials. It is not a standalone test, and long-term side effects or loss of effectiveness are still possible. The drug is investigational and not yet approved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 468 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication * Has continued the same antidepressant medication at the stable dose/day throughout CYB003-002 APPROACH or CYB003-003 EMBRACE * Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form * Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP * Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP * Female participants must have a negative pregnancy test at Baseline (the end of trial \[EOT\] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day Exclusion Criteria: * newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial * Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation/attempt or self-harm in CYB003-002 APPROACH OR has had a \>1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH * Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial * Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND * Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial * Positive urine test for drugs of abuse, or alcohol breath test prior to dosing. * Unwilling to consent to audio and video recording of psychological support and dosing sessions

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Adams Clinical Boston

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Bronx

    The Bronx, New York, 10461, United States

  • Adams Clinical Harlem

    New York, New York, 10029, United States

  • Atlanta Center For Medical Research

    Atlanta, Georgia, 30331, United States

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • CenExel iResearch

    Savannah, Georgia, 31405, United States

  • Cenexel iResearcvh Atlanta, LLC

    Atlanta, Georgia, 30030, United States

  • Charter Research

    Orlando, Florida, 32803, United States

  • Clinical Neuroscience Solutions, CNS Healthcare

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801, United States

  • Combined Research Orlando

    Phoenix, Arizona, 85022, United States

  • InSite Clinical Research, LLC

    DeSoto, Texas, 75115, United States

  • Inland Psychiatric Medical Group Inc (IPMG Research)

    San Juan Capistrano, California, 92675, United States

  • K2 Medical Research

    Lady Lake, Florida, 32159, United States

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • Monash University - Notting Hill

    Notting Hill, Victoria, 3168, Australia

  • Mountain View Clinical Research

    Denver, Colorado, 80209, United States

  • Neurobehavioral Clinical Research

    Canton, Ohio, 44720, United States

  • Neurocentrix Research

    Carlton, Victoria, 3053, Australia

  • Open Mind Collective / UCSF Medical Center - Mount Zion

    San Francisco, California, 94114, United States

  • Psychiatric Medicine Associates

    Skokie, Illinois, 60076, United States

  • Psychiatric Medicine Associates, LLC

    Skokie, Illinois, 60076, United States

  • Ramsay Clinic

    Melbourne, Victoria, 3004, Australia

  • Redbird Research

    Las Vegas, Nevada, 89119, United States

  • Research Centers of America

    Hollywood, Florida, 33024, United States

  • Segal Trials Center for Psychedelic Research

    Lauderhill, Florida, 33319, United States

  • Starlight Clinical Research

    Evergreen, Colorado, 80439, United States

  • Sunstone Medical, PC

    Rockville, Maryland, 20850, United States

  • Sydney Local Health District

    Camperdown, New South Wales, 2050, Australia

  • Thompson Brain & Mind Healthcare

    Maroochydore, Queensland, 4558, Australia

  • Uptown Research Institute

    Chicago, Illinois, 60640, United States

  • Zillan Clinical Research

    Houston, Texas, 77082, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.