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Depression

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

Recruiting · Charlestown, Massachusetts

Study treatment at no costPHASE3

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • 18-55 years old
  • Have major depressive disorder (MDD) confirmed by a structured interview
  • Have at least moderate depression symptoms based on SIGH-ADS scores (≥18 at screening and baseline)
  • Have tried 1-4 antidepressant treatments for the current episode but did not respond well enough
  • Are able to sign the informed consent and follow all study visits and assessments

🚫 You may not be able to join if…

  • A history of schizophrenia, bipolar disorder, or other serious psychiatric conditions (including borderline personality disorder)
  • A positive MRI screening (for example metal implant or severe claustrophobia)
  • Prior electroconvulsive therapy and/or ketamine for the current episode
  • Current alcohol or substance abuse within the last year or a positive drug screen before dosing
  • Pregnant, nursing, or planning pregnancy (and women who could become pregnant must have a negative urine pregnancy test)

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 18–55
  • Have Depression
  • !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
  • !Not for people who are pregnant or breastfeeding

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.

Is it safe? Who makes sure of that?+

This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT06247839 · Locations: Massachusetts