Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinRecruiting

Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)

This retrospective registration trial investigates the effectiveness of psychedelic therapy for Treatment Resistant Depression (TRD).

Target Enrollment
30 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Open-label, non-randomised interventional service trial delivering psilocybin-assisted psychotherapy for TRD with 2–3 medicine days (usual 25 mg oral psilocybin; optional 10 mg top-up) interleaved with preparatory and integration psychotherapy.

Therapy comprises three 60-minute preparation sessions, a 6–7 hour dosing day with supportive, client-centred psychotherapy, and three 60-minute integration sessions after each dosing day. Sessions may be delivered face-to-face or via Zoom by HREC-approved therapists and the treating psychiatrist; adverse events and psychometrics are recorded.

Study Protocol

Preparation

3 sessions
60 min each

Dosing

3 sessions
420 min each

Integration

9 sessions
60 min each

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Oral psilocybin with preparatory and integration psychotherapy; 2–3 medicine days with optional top-up.

Interventions

  • Psilocybin25 mg
    via Oral• up to 3 single doses• 3 doses total

    Usual 25 mg given once in morning on medicine days; optional 10 mg top-up if inadequate response; top-up given same day.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Must suffer from TRD

Exclusion Criteria

  • (1) Is not able to give adequate informed consent, or is under 18 or over 65 years old.
  • (2) Has uncontrolled hypertension or unstable diabetes.
  • (3) Has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds corrected by Bazett's formula).
  • (4) Has a history of additional risk factors for Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
  • (5) Has evidence or history of significant medical disorders e.g. epilepsy, stroke, unstable cardiovascular disease.
  • (6) Has symptomatic liver disease.
  • (7) Has a history of hyponatremia or hyperthermia.
  • (8) Weighs less than 48 kg.
  • (9) Is pregnant or nursing or is of childbearing age and is not practicing an effective means of birth control.
  • (10) Is currently abusing illegal drugs

Study Details

Locations

Unknown facility — Australia

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