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A Phase 2A randomised double-blind active-placebo-controlled trial to assess the safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder

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Trial Profile

A Phase 2A randomised double-blind active-placebo-controlled trial to assess the safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Aug 2022

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At a glance

  • Drugs Psilocybin (Primary)
  • Indications Generalised anxiety disorder
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms Psi-GAD

    • Most Recent Events

    • 03 Aug 2022 New trial record
    • 27 Jul 2022 According to an Incannex Healthcare media release, 22 participants are enrolled in the trial and the remaining 8 participants are anticipated to be enrolled during the current quarter. This trial led by Dr Paul Liknaitzky at Monash University.
    • 27 Jul 2022 According to an Incannex Healthcare media release, the trial protocol has been discussed with FDA officials in a pre-IND meeting undertaken in the December quarter of 2021.A preliminary analysis of patient data will be conducted by an independent data safety monitoring board after 30 patients have completed primary endpoint assessment. This preliminary analysis will allow the trial investigators to inform the second part of the trial (n=42) and/or the follow-up pivotal phase 2b clinical trial.

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