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Magic mushroom microdoses could lift Treatment-Resistant depression

NCT ID NCT07183748

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether very small, repeated doses of psilocybin (the active ingredient in magic mushrooms) combined with talk therapy can safely reduce depression symptoms in people who haven't gotten better with standard treatments. Twenty adults aged 18-65 with treatment-resistant depression will receive either psilocybin or a placebo for six weeks, along with psychotherapy. Researchers will track mood, thinking skills, and biological markers like stress hormones.

What this could mean

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

Active substance
psilocybin
What this could lead to
If it works, this could point toward a new option for people with depression that hasn't responded to other treatments.
What could go wrong
This is a very small early-phase study with only 20 people. It may not show clear benefits, and participants must stop their usual medications, which carries risks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 65 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: * Age range between 18-65 years. * Diagnosis of treatment-resistant major depression as defined by the DSM-IV criteria (309.81) (ASA 1994) and determined by the BDI (BDI-II, 1996). * Willingness to discontinue psychiatric medication starting two weeks prior to the beginning of the study and throughout its duration, as well as to cease the use of drugs and licensed cannabis, and to suspend psychotherapy for the duration of the study. Participants also commit not to initiate psychiatric medication or psychotherapy during the study without consulting the research team. All under supervision within a day treatment framework. * Abstinence from drugs and other psychiatric medications. * Negative pregnancy test for women, and use of contraception by both men and women during the study period. * Willingness to sign a confidentiality waiver allowing the research team to consult with the participant's treating physician. * Willingness to provide the contact information of a close and relevant person in case suicidal ideation arises. * Commitment to participate in all stages of the study, including follow-up assessments. * Willingness not to participate in another study during the current study period. Exclusion Criteria: * Investigators and their immediate family members are not permitted to participate in the study. Immediate family is defined as the investigator's spouse, parent, child, grandparent, or grandchild. * Pregnant women, breastfeeding women, or women of childbearing age who are not using medically approved contraceptive methods (e.g., condoms). Men who are sexually active and may cause pregnancy but are unwilling to use contraception. * Significant unstable physical illness (including cardiac, hepatic, renal, respiratory, endocrinological, neurological, or hematological conditions), based on the investigator's judgment. * Psychotic spectrum disorders. * Bipolar disorder. * Post-traumatic disorder involving dissociative symptoms. * Uncontrolled anxiety disorder. * Chronic perceptual disorder (HPPD). * Head injury or cognitive impairment (including intellectual disability or dementia). * Severe suicidal risk or aggressive behavior toward others, as assessed by the investigator and standardized depression/suicide assessment questionnaires. History of chronic benzodiazepine use (at least 4 mg lorazepam daily for over two years), or signs and symptoms of benzodiazepine use within two weeks prior to randomization. * Alcohol and/or substance abuse within the past 6 months, based on the clinical judgment of the investigator. * Any active addiction (substance use disorder). * Current or past epilepsy. * Individuals with focal or generalized encephalopathy (e.g., tumor, stroke, meningitis, encephalitis), or head trauma that may be epileptogenic.

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Mental Health Center Beer Sheva

    RECRUITING

    Beersheba, Israel

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