Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPsilocybinNot yet recruiting

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.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

Randomised, parallel-group Phase II study comparing a Fly-In-Fly-Out psilocybin-assisted therapy programme (single 25 mg oral dose plus preparatory and integration psychotherapy) with a waitlist treatment-as-usual control; participants are randomised to PAT+journaling, PAT+VR, or waitlist, with waitlist participants offered PAT after 10 weeks.

Intervention includes three 90-minute preparatory sessions, one dosing session (25 mg psilocybin capsule) and three 90-minute integration sessions; home integration supported by a VR environment (15 minutes, 3–4× weekly suggested) or a reflective journal. Therapists are PAT-trained and receive ongoing supervision.

Study Protocol

Preparation

3 sessions
90 min each

Dosing

1 sessions

Integration

3 sessions
90 min each

Therapeutic Protocol

support

Study Arms & Interventions

PAT + journaling

experimental

Psilocybin-assisted therapy with journaling-supported integration; single 25 mg oral psilocybin dose plus preparatory and integration psychotherapy sessions and home journaling.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg oral psilocybin capsule; paired with three 90-minute prep and three 90-minute integration sessions and home journaling.

PAT + VR

experimental

Psilocybin-assisted therapy with VR-supported integration; single 25 mg oral psilocybin dose plus preparatory and integration psychotherapy sessions and VR headset for home use.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg oral psilocybin capsule; paired with three 90-minute prep and three 90-minute integration sessions and VR headset for home integration.

Waitlist (TAU)

waitlist

Treatment as usual (participants continue with their regular psychotherapist at the partner clinic) and commence experimental PAT after 10 weeks.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

  • Be aged 18 to 75 years.
  • Meet DSM-5 criteria for Major Depressive Disorder.
  • Score at least 20 on the MADRS at screening.
  • Be engaged in psychological services at the trial partner clinic, have completed at least four sessions, and attend at least monthly on average.

Exclusion Criteria

  • Have a current or lifetime history of meeting DSM-5 criteria for Schizophrenia, other Psychotic Disorder, Dissociative Identity Disorder, or Bipolar I or II Disorder or other mood disorder with psychotic features.
  • Have a current or past year history of meeting DSM-5 criteria for alcohol or drug dependence (excluding caffeine and nicotine), if determined by the PI or Study Physician to be incompatible with safe exposure to psilocybin.
  • Have current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the AP or treating team.
  • Require ongoing concomitant therapy with an excluded medication.

Study Details

Locations

Unknown facility — Australia

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