A Double-Blind Randomised Controlled Trial of the Efficacy of Microdosing with Psilocybin to treat Moderate Depression

This double-blind randomised controlled trial (n=293) aims to evaluate the efficacy of microdosing with psilocybin as a treatment for moderate depression.

Conducted by Macquarie University, Australia, the study involves participants aged 18 or above with moderate depression. The intervention consists of a six-week course of low-dose psilocybin capsules (4mg) administered every 3-4 days, with 11 doses in total. A neuroimaging substudy will investigate neuroplasticity markers in 80 participants.

The primary outcome measure is the change in the GRID-Hamilton Depression Rating Scale from baseline to week 6. Secondary outcomes include various psychological measures, neurophysiological measures, and omics-based biomarkers. Participants will be monitored closely throughout the trial, with adherence confirmed by trial staff.

The trial, funded by Woke Pharmaceuticals, is anticipated to start recruitment in October 2023 and conclude data collection in January 2028. Dr Vince Polito is the principal investigator.

Topic Depression Microdosing
Compound Psilocybin
Country Australia
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

Macquarie University
Macquarie University in Australia is actively involved in pioneering research into the use of psychedelics, particularly focusing on their potential to treat mental health issues and enhance cognitive performance. Dr. Vince Polito, a senior lecturer and senior research fellow at the School of Psychological Sciences, leads several of these innovative studies.

Woke Pharmaceuticals
Woke Pharmaceuticals is an Australian biotech company developing novel psychedelic compounds.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.