Psilocybin for Depression

Overseen by Deepak D'Souza, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Yale University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if psilocybin, a compound from mushrooms, can help people with major depression by making their brains more adaptable and improving their symptoms. Psilocybin has shown promise as a treatment for depression in various studies, indicating its potential to improve depressive symptoms.

Research Team

Deepak D'Souza, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults with Major Depressive Disorder who haven't improved after trying at least one antidepressant. Participants must be currently seeing a mental health professional and not have any psychotic disorders, drug abuse issues, or unstable medical conditions. Pregnant or breastfeeding individuals are excluded, as well as those without proper birth control.

Inclusion Criteria

I have been diagnosed with Major Depressive Disorder and am currently experiencing a depressive episode.

My current depression treatment hasn't worked.

I am currently seeing a mental health professional.

Exclusion Criteria

Pregnant, breastfeeding, lack of adequate birth control

A close family member has a severe mental health condition.

Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)

Treatment Details

Interventions

• Placebo (Placebo)
• Psilocybin (Psychedelic)

Trial Overview The study tests if psilocybin can cause changes in the brain that improve depression symptoms. It compares the effects of two different doses of psilocybin to a placebo (a substance with no active drug).

Participant Groups

Group I: Placebo/Medium Dose Psilocybin Experimental Treatment 2 Interventions

Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.

Group II: Placebo/Low Dose Psilocybin Experimental Treatment 2 Interventions

Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.

Group III: Medium Dose Psilocybin/Placebo Experimental Treatment 2 Interventions

Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.

Group IV: Low Dose Psilocybin/Placebo Experimental Treatment 2 Interventions

Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Heffter Research Institute

Collaborator

Trials

15

Recruited

520+