Psilocybin-Assisted Therapy as a Treatment for Depression (NCT07582120) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Psilocybin-Assisted Therapy as a Treatment for Depression
United States50 participantsStarted 2026-06
Plain-language summary
Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants.
In clinical trials, psilocybin has shown promise as a treatment for depression due to its rapid onset of antidepressant effects and sustained benefits.
This study will use MRI scanning of the brain and other biological measures (biomarkers) to investigate how psilocybin affects brain activity and psychological flexibility before, during, and after receiving psilocybin in participants with depressive symptoms.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18 years
. Participants of childbearing potential must agree to practice 2 forms of effective birth control throughout the duration of the study
. Females of childbearing potential must have a negative urine pregnancy test at Screening and prior to dosing on Dosing Day
. Diagnosis of depression at Screening via the SCID-5-CT interview and MADRS score of ≥7
. Have an identified support person Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterize ACUTE (~1 week post-dose) and PERSISTING (~30 days post-dose) effects of PAT in depressed adults at two possible administrations on depression symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS) score.
Timeframe: 1 week and 30 days post-dose for both administration sessions
2
Characterize ACUTE (~1 week post-dose) and PERSISTING (~30 days post-dose) effects of PAT in depressed adults at two possible administrations on psychological flexibility using the Multidimensional Psychological Flexibility Inventory (MPFI).
Timeframe: 1 week and 30 days post-dose for both administration sessions
. Is currently pregnant or breastfeeding, or plan to become pregnant or breastfeed within the study period
. Has had Electroconvulsive Therapy, Transmagnetic Stimulation, Vagus Nerve Stimulation or Deep Brain Stimulation treatment within the last 12 months
. Is currently taking a medication on the prohibited medications list, such as heterocyclic (tricyclic, tetracyclic) antidepressants, monoamine oxidase inhibitors (MAOIs), antipsychotic augmentation therapy, or is taking more than one medication for the treatment of depression:
. Participants who are taking a single prescription medication for depression must be on a stable, minimally therapeutic/tolerated dose for at least 4 weeks prior to Screening.
. Psychostimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) are allowed, if used at a stable dose or pattern for at least 6-weeks prior to Screening and not used on Dosing Day(s).
. Has a primary psychotic disorder diagnosis
. Has a first-degree relative with a known history of a psychotic disorder