Magic mushroom compound could restore joy in depressed patients
NCT ID NCT07607938
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This early-stage study tests whether a single 25 mg dose of psilocybin can help people who still feel emotionally flat or uninterested in things despite taking antidepressants. About 90 adults aged 18-65 will receive either psilocybin or a placebo, and researchers will use brain scans and questionnaires to measure changes in mood and brain activity. The goal is to see if psilocybin can safely improve these lingering symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 between 18 and 65 years * Able to provide voluntary signed and dated informed consent. * Females of childbearing potential (FOCBP) must agree to practice an effective means of birth control throughout the duration of the trial * Males who have FOCBPs as partners must agree to practice an effective means of birth control throughout the duration of the trial * State willingness to comply and be available for all study requirements, including psychological, cognitive, imaging and procedural evaluations for the duration of the study * Meet DSM-5 criteria for major depressive disorder (MDD) * Screening Dimensional Anhedonia Rating Scale (DARS) total score of \< 28.5 points * Have an identified support person * Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator. Exclusion Criteria: * Inability to speak and understand English sufficiently to complete informed consent and study procedures. * Inability to provide informed consent. * Women who are pregnant or who intend to become pregnant or nurse during the study duration. * Prior exposure to classic psychedelics (i.e., psilocybin, LSD, ayahuasca, and/or mescaline) within the past 1 year. * Current or previous psychiatric conditions that meet DSM-5 criteria for psychotic disorders (i.e., schizophrenia, schizoaffective disorder, MDD with psychosis), bipolar 1 or 2 disorder, or current diagnosis of active substance use disorder. * Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS assessment (severity score \> 3) at the Screening visit, confirmed by the Investigator. * Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator. * Immediate family history (i.e., parents, full siblings, or half siblings) with known or suspected psychotic disorder. * Presence of medical conditions that may confound results of imaging study or that are contraindications to or psilocybin exposure (i.e., neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy); * Presence of contraindications to MRI scanning (implantable devices, bone hardware, various IUD). * Participants who received electroconvulsive therapy (ECT), trans magnetic cranial stimulation (TMS), and/or ketamine in the past 90 days. * Has any other physical or psychological symptom, medication, or other relevant finding prior to randomization that, based on the clinical judgment of trial personnel, would make a participant unsuitable for the trial. * Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements.
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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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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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