Monash University in Australia has obtained ethics approval for a world-first clinical trial investigating psilocybin-assisted psychotherapy in the treatment of severe Generalised Anxiety Disorder.

In partnership with Incannex Healthcare, the randomised triple-blinded active-placebo-controlled trial, led by Dr Paul Liknaitzky, Head of Clinical Psychedelic Research at Monash University, will assess the safety and efficacy of psilocybin-assisted psychotherapy alongside exploring how the treatment works.

Looking to recruit 72 participants, it is set to be the largest psychedelic research and development project in Australia and will include psilocybin sessions alongside a program of specialised psychotherapy.

Generalised Anxiety Disorder (GAD) is a condition that involves intense anxiety and worry most of the time and can be so excessive that everyday life becomes difficult. Experienced by more women than men, nearly six per cent of the Australian population will experience GAD in their lifetime, with current treatments providing inadequate outcomes, problematic side-effects, and high relapse rates.

Evidence is accumulating that psychotherapy assisted by psilocybin can provide significant and lasting benefits across a range of mental health and addiction disorders.