Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPsilocybinPlaceboActive not recruiting

Psilocybin – Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Double-blind, randomised, placebo-controlled crossover Phase I study (n=18) with two dosing sessions ~4 weeks apart comparing placebo, low-dose psilocybin (0.1 mg/kg) and medium-dose psilocybin (0.3 mg/kg) in people with major depressive disorder to assess neuroplasticity and symptom change.

Target Enrollment
18 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

This randomised, double-blind crossover study enrolls 18 participants with Major Depressive Disorder to receive two of three interventions across two sessions (~4 weeks apart): placebo, low-dose psilocybin (0.1 mg/kg) or medium-dose psilocybin (0.3 mg/kg). The primary purpose is treatment and to evaluate psilocybin-induced neuroplasticity alongside clinical response.

Outcomes include neuroimaging and biomarkers of plasticity and clinical measures of depression; standard safety monitoring and urine toxicology are used. Participants must have failed at least one adequate antidepressant trial and be engaged with a mental health clinician.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Low dose psilocybin

experimental

0.1 mg/kg psilocybin capsule in crossover session.

Interventions

  • Psilocybin0.1 mg/kg
    via Oral• single dose• 1 doses total

    0.1 mg/kg oral capsule

Medium dose psilocybin

experimental

0.3 mg/kg psilocybin capsule in crossover session.

Interventions

  • Psilocybin0.3 mg/kg
    via Oral• single dose• 1 doses total

    0.3 mg/kg oral capsule

Placebo

inactive

Microcrystalline cellulose capsule used as placebo control in crossover.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Microcrystalline cellulose capsule (placebo)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE)
  • Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode
  • Currently engaged in treatment with a mental health clinician

Exclusion Criteria

  • Exclusion Criteria:
  • Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
  • Axis I psychotic disorder in first degree relative
  • Currently taking a conventional antidepressant medication
  • Unstable medical or neurological conditions
  • Significant cognitive disorders
  • History of intolerance to drugs known to significantly alter perception (e.g., psilocybin, LSD, salvinorin A, mescaline)
  • Pregnant or breastfeeding or lack of adequate birth control
  • Urine toxicology positive to drugs of abuse on experimental test days

Study Details

Locations

VA Connecticut Healthcare System, West Haven Campus — West Haven, Connecticut, United States

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