RecruitingPhase 1ACTRN12623000832673

Treatment Resistant Depression Intervention with Psilocybin-assisted Psychotherapy

Investigating the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression.


Sponsor

St. Vincent's Hospital, Sydney

Enrollment

20 participants

Start Date

May 22, 2024

Study Type

Interventional

Conditions

Summary

This is a single centre, single arm study primarily examining the the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression patients who are on concurrent psychotropic medication.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Treatment-resistant depression is one of the most challenging conditions in psychiatry — affecting people who have tried multiple antidepressants without meaningful relief. Psilocybin, the active compound in certain mushrooms, has shown remarkable promise in clinical research as a way to break entrenched depressive patterns, particularly when combined with structured psychological support. However, most previous trials have excluded people who are currently taking psychiatric medications. This Australian study is specifically designed to test psilocybin-assisted psychotherapy in people who are on concurrent antidepressant or antipsychotic medication — reflecting the real-world situation of many treatment-resistant patients. The focus is on safety and feasibility: can this treatment be delivered safely alongside existing medications, and is it acceptable to patients? You may be eligible if you are aged 18 to 75, have a confirmed diagnosis of Major Depressive Disorder, have failed at least two classes of antidepressants, are currently under the care of a psychiatrist, and are willing to remain in Sydney for the duration of the study. People with psychosis, bipolar disorder, epilepsy, or a first-degree relative with psychosis are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Psilocybin-assisted psychotherapy consisting of pre psilocybin psychotherapy session/s (preparation), a psilocybin dosing day and post dosing psychotherapy sessions/s (integration). The initial dos

Psilocybin-assisted psychotherapy consisting of pre psilocybin psychotherapy session/s (preparation), a psilocybin dosing day and post dosing psychotherapy sessions/s (integration). The initial dose of psilocybin to be administered to all participants will be a 15 mg oral capsule. Study clinicians will assess safety and tolerability post each dosing and only eligible participants will receive a subsequent dose/s (ranging from min 15 mg to maximum 45 mg psilocybin). Minimum number of dosing sessions during the study participation is 1 and maximum 5. Time between all dosing sessions will be at least one week. All dosing sessions will be supervised by a dyad of trained therapists for approximately 7-8 hours. The psychotherapy sessions prior to dosing (preparation) and post dosing (integration) will occur face to face. The first dosing session is preceded by three preparation sessions and proceeded by two therapy sessions, each of 1 hour duration. Preparation session/s will involve: building therapeutic alliance, psychological and practical preparation for dosing sessions, non-avoidance training, nature of and relationship to distress and anxiety management strategies, intention setting and planning for continuity of care. Dosing session/s will involve: Delivery of psilocybin dose in the presence of a therapy dyad and non-directive supervision for 8 hours in the context of a safe and comfortable environment and a curated music playlist. Integration session/s will involve: Assisting the participant in the formation of a narrative of the psychedelic experience, promoting meaning-centred integration of this narrative into the participants experience, encouraging and motivating behaviour change as a result of the above, encouraging ongoing engagement with emotional and somatic experiences and planning for ongoing support and return to usual care.


Locations(1)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12623000832673


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