Magic mushroom microdoses could lift Treatment-Resistant depression
NCT ID NCT07183748
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Mental Health Center Beer Sheva
RECRUITINGBeersheba, Israel
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