Effectiveness of Psychedelic Therapy for... — Clinical Trial Details

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.

Must suffer from TRD

(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

Company

Product

Legal

Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details