Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinActive not recruiting

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Open-label, single-group Phase II study (n=27 actual) assessing a single 25 mg oral psilocybin dose under supportive conditions for adults with treatment-resistant depression.

Target Enrollment
27 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label single-group Phase II trial administering 25 mg oral psilocybin (COMP360) to adults with treatment-resistant depression under supportive therapeutic conditions; primary purpose is treatment.

Actual enrolment reported as 27. CA site includes a re-dosing option for participants with symptom exacerbation at least 12 months after initial dosing; outcomes include depressive symptom change and safety/tolerability measures.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single-group open-label 25 mg psilocybin; CA site may re-dose participants with symptom exacerbation ≥12 months after initial dosing.

Interventions

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

    COMP360 (psilocybin); open-label

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosis of at least moderate Major Depressive Disorder (MDD)
  • Age 18–65 years
  • See protocol for full criteria.

Exclusion Criteria

  • Exclusion Criteria:
  • Comorbidities (see protocol for details)
  • Note for CA site: Only Veterans are eligible at the CA site.

Study Details

Locations

VA Palo Alto Healthcare System/Stanford Medicine — Palo Alto, California, United States
Sheppard Pratt Health System — Baltimore, Maryland, United States

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