Clinical TrialMajor Depressive Disorder (MDD)PsilocybinKetamineUnknown status

Psilocybin and Depression

Randomized, double-blind, parallel Phase II trial (n=60) comparing a single oral 25 mg psilocybin dose, intranasal 125 mg ketamine, and a no-treatment group in participants with severe major depressive disorder; outcomes include depression severity and fMRI biomarkers.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomized, double-blind, parallel study (n=60) compares single-dose psilocybin (25 mg, oral) with intranasal ketamine (125 mg) and a no-treatment group in participants with moderate-to-severe major depressive disorder.

Depression severity is assessed at baseline and at 1 week, 3 months and 6 months after dosing. Functional MRI is performed before and one week after administration to identify brain-network changes associated with clinical response.

Blood samples are collected to investigate gene expression and molecular correlates of rapid antidepressant effects and to explore biomarkers predictive of outcome.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Single oral 25 mg psilocybin under supervised conditions.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single oral 25 mg psilocybin.

Ketamine

active comparator

Single intranasal 125 mg ketamine under supervised conditions.

Interventions

  • Ketamine125 mg
    via Other• single dose• 1 doses total

    Intranasal administration (125 mg).

No treatment

waitlist

No-treatment comparator; assessments only.

Interventions

  • Compound

    No treatment — assessments only; remote follow-up for symptom ratings.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
  • 2. No health-related contraindications.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Current or previously diagnosed psychotic disorder.
  • 2. Immediate family member with a diagnosed psychotic disorder.
  • 3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).
  • 4. History of suicide attempts.
  • 5. History of mania.
  • 6. Current 5-HT2A antagonist antidepressant medication.
  • 7. Blood or needle phobia.
  • 8. Positive pregnancy test.
  • 9. Current drug or alcohol dependence.
  • 10. Lack of appropriate use of contraception.
  • 11. Breast-feeding.

Study Details

Locations

Finland

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