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Psilocybin-Assisted Therapy as a Treatment for Depression

A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how psilocybin affects brain activity and the ability to adapt thoughts and feelings in people with depression. Researchers will use MRI brain scans and other body measures before, during, and after treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be older than 18.
  • You must have depression confirmed by a study interview and a score of at least 7 on the MADRS depression scale.
  • If you can become pregnant, you must use 2 effective forms of birth control throughout the study.
  • If you can become pregnant, you must have negative urine pregnancy tests at screening and before taking the study drug.
  • You must name a support person and agree to have them or another responsible person take you home or to a safe place after dosing.

Who can't join

  • You cannot read or understand English, or you are pregnant, breastfeeding, or planning either during the study.
  • You had electrical, magnetic, or implanted-device treatment for depression in the past 12 months. An implanted vagus nerve or deep brain stimulation device rules out brain scans, even if turned off.
  • You take a banned medicine or more than one depression medicine. One depression medicine is allowed only at a stable, tolerated treatment dose for at least 4 weeks before screening. ADHD stimulants require a stable dose or use pattern for 6 weeks and cannot be taken on dosing days.
  • You have a primary psychotic disorder—a condition that affects knowing what is real—or a parent, sibling, or child has a history of one.
  • You have a substance use disorder now or had one within 6 months before screening, used listed psychedelic drugs within that time, or have a known sensitivity to psychedelic medicines.
  • You have a positive urine test for a listed drug. The list includes cocaine, opioids, sedatives, amphetamines, MDMA, and PCP; prescribed methamphetamine is an exception.
  • You have an unstable health condition, serious blood test or heart tracing results, or medicines that make participation unsafe. Blood pressure above 140/90 at both screening and baseline, or before dosing on dosing day, also rules you out.
  • You are at high risk for suicide and cannot be kept safe, such as being unwilling to enter a hospital when needed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age \> 18 years 2. Participants of childbearing potential must agree to practice 2 forms of effective birth control throughout the duration of the study 3. Females of childbearing potential must have a negative urine pregnancy test at Screening and prior to dosing on Dosing Day 4. Diagnosis of depression at Screening via the SCID-5-CT interview and MADRS score of ≥7 5. 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: 1. Unable to read or understand English 2. Is currently pregnant or breastfeeding, or plan to become pregnant or breastfeed within the study period 3. Has had Electroconvulsive Therapy, Transmagnetic Stimulation, Vagus Nerve Stimulation or Deep Brain Stimulation treatment within the last 12 months a. Participants with VNS or DBS devices in place- including devices that are inactive or turned off will not be eligible to participate in the imaging portion of the study 4. 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: 1. 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. 2. 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). 5. Has a primary psychotic disorder diagnosis 6. Has a first-degree relative with a known history of a psychotic disorder 7. Meets criteria for substance use disorder or diagnosis of substance use disorder within 6 months prior to Screening 8. Has an unstable medical condition or serious abnormalities of complete blood count, chemistries, or ECG, or taking medications that in the opinion of the study clinician would preclude safe participation in the trial 9. Is at risk for hypertensive crisis defined as: 1. BP at Screening AND Baseline \>140/90 mmHG 2. BP on Dosing Day prior to dosing \>140/90 mmHG 10. Has used a serotonergic hallucinogenic substance (e.g., psilocybin, lysergic acid diethylamide (LSD), mescaline, N,N-dimethyltryptamine (DMT), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 3,4-methylenedioxymethamphetamine (MDMA), or other related substances) within 6 months of Screening. 11. Has a known sensitivity to psychedelic medications 12. Has a positive urine drug test including amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, methamphetamine (unless prescribed), MDMA, methadone, opiates, and phencyclidine (PCP) 13. Is at high risk for suicide (e.g., active suicidal ideation and or current intent or plan) and unable to be managed safely (i.e., unwilling to be hospitalized)

Study sites (1)

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