Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)

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

Led by Prof Dr. Ranil Gunewardene from Mindlife Clinic at Northern Beaches Hospital, the trial aims to measure the effectiveness of psilocybin combined with talking therapy in real-world patient groups suffering from TRD.

The trial involves administering psilocybin medicines orally in capsule form, alongside psychotherapy sessions, which include preparatory, dosing, and integration sessions. The dosing sessions last approximately 6-7 hours and are conducted under the supervision of Dr. Ranil Gunewardene. The therapy approach focuses on supportive psychotherapy, with emphasis on patient-centred experiences and perspective shifts guided by the patient’s inner healing intelligence.

Primary outcomes include changes in clinician-rated depression severity measured by the Montgomery–Åsberg Depression Rating Scale (MADRS) and secondary outcomes such as changes in self-rated mental health, suicidal ideation, disability, connection, quality of relationships, mystical experiences, alcohol use, drug use, eating attitudes, and eating disorder symptomology.

The trial targets individuals aged 18 to 65 suffering from TRD in New South Wales, Australia. It is a non-randomised trial with no control group, and recruitment is ongoing. The trial is self-funded and has received ethics approval from the Townsville Hospital and Health Service Human Research Ethics Committee. Individual participant data (IPD) will not be available for sharing, but summary results will be provided. For inquiries, A/Prof Dr. Ranil Gunewardene can be contacted at Mindlife Clinic.

Trial Details

We intend to measure the effectiveness of psilocybin when combined with talking therapy for the treatment of Treatment Resistant Depression (TRD) in real world patient groups We will test how effective psilocybin is for TRD and treat patients who have had limited benefit from existing treatments for these hard to treat conditions

NCT Number ACTRN12624000040561

Data attribution

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