This open-label trial (n=50) will assess the safety and efficacy of psilocybin-assisted psychotherapy in patients with treatment-resistant major depressive disorder (TRD) in an Australian clinical setting. Participants will receive two doses of psilocybin (25mg each) alongside a structured programme of preparatory and integration psychotherapy sessions over approximately 16–18 weeks.
The study, conducted by GoodMind Therapeutics and funded by GM Therapeutics Pty Ltd, aims to determine whether psilocybin can significantly improve depression symptoms in individuals who have not responded to at least two prior antidepressant treatments.
Primary outcomes will be measured using the GRID-Hamilton Depression Rating Scale (GRID-HAMD), with additional assessments including patient-reported mood changes and quality of life metrics. Safety will be monitored through a structured adverse effects questionnaire. Participants must be 18 or older, fluent in English, and clinically stable, with exclusions including a history of psychosis, cardiovascular disease, or pregnancy. The trial is set to take place across multiple Australian states, with anticipated recruitment beginning in November 2024.
Trial Details
In this study, patients diagnosed with treatment-resistant depression will undergo a comprehensive intervention combining psychotherapy with psilocybin treatment. Participants will receive two separate doses of 25 mg psilocybin capsules in two separate dosing sessions which will occur at visit 5 and 9, the first dosing session takes place after 3 psychotherapy preparation sessions and followed by a structured course of 3 psychotherapy integration sessions, followed by a second dosing session and a further 3 integration sessions. The entire treatment process will include 12 therapeutic sessions which may span approximately 16 to 18 weeks as appointments do not necessarily have to take pace weekly, they will involve both clinician and patient assessments to evaluate outcomes. After the patient is screened and onboarded, there are Monitoring attendance at scheduled preparation, dosing, and integration sessions will take place to ensure participants are following the therapy schedule, dosing session and the administration of medication will only occur under close, direct supervision. Post treatment process the patients will be followed up at 4 weeks and 6 months intervals. Psilocybin-assisted therapy involves preparatory sessions to establish therapeutic goals and ensure readiness, followed by guided dosing sessions where the therapist supports the participant through their psychedelic experience, and integration sessions to help process and incorporate insights gained during the experience into everyday life. The therapy is designed to facilitate deep psychological exploration, emotional processing, and personal growth, with the therapist providing support and guidance throughout the process. Sessions will be 60 minutes in duration and generally weekly, depending on patient/clinician availability and schedule. The preferred mode of administration is face to face, however, patient requests for telehealth will be considered. However, the initial assessment and dosing sessions must always be face to face. Strategies to assess adherence in psilocybin-assisted therapy include tracking attendance at scheduled sessions, monitoring completion of preparatory and integration sessions, and reviewing self-reported logs or diaries where participants document their experiences and adherence to the intervention. Additionally, therapists may conduct regular check-ins and follow-ups to ensure participants are engaging with the therapy as planned and address any issues that arise.Trial Number ACTRN12624001343594p