FIFO-PAT-20: A sequential multiple assignment randomised controlled trial comparing the efficacy and safety of treatment as usual against a Fly-In-Fly-Out (FIFO) model of Psilocybin-Assisted Therapy (PAT) for Major Depressive Disorder (MDD), alongside randomised adjunctive support (virtual-reality vs journalling)

This open-label, randomised controlled Phase II trial (n=30) will test a six-week Fly-In-Fly-Out Psilocybin-Assisted Therapy (FIFO-PAT) programme for major depressive disorder (MDD), using a single 25 mg oral dose of psilocybin alongside psychotherapy and either a virtual-reality (VR) integration tool or journaling.

The study, led by Monash University in collaboration with industry partners including White Rabbit Ventures, Enosis Therapeutics, and PsychologyCare, will compare FIFO-PAT against treatment as usual (standard psychological care) in adults aged 18–75 already engaged with the partner clinic. Participants will first undergo three preparatory psychotherapy sessions, then a supervised psilocybin dosing session, followed by three integration sessions to help process and apply insights from the psychedelic experience. Integration will be supported by either a VR environment—depicting a natural landscape for guided reflection—or journaling, with both tools intended to encourage self-reflection between therapy sessions.

Randomisation occurs twice: first to immediate treatment or a 10-week waitlist, and second to either VR or journaling. Depression severity will be measured primarily using the Montgomery–Åsberg Depression Rating Scale (MADRS) at week 10, with additional outcomes including remission rates, changes in anxiety, substance use, work performance, and quality of life. Participants will be monitored for up to 46 weeks to assess long-term effects, safety, and treatment acceptability. The FIFO model—where specialist psychedelic therapists travel in only for the treatment phase—is being evaluated as a potentially scalable approach for delivering psilocybin-assisted therapy in real-world clinical settings.

Topic Depression
Compound Psilocybin
Country Australia
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Sponsors & Collaborators

Monash University
The Clinical Psychedelic Lab, established in 2020, within the Dept Psychiatry at Monash University is the first of its kind in Australia, leading the development and implementation of psychedelic therapies. The lab has played a central role in establishing the field of clinical psychedelic research in Australia.

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