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
Status Not yet recruiting
Results Published No
Start date 09 October 2023
End date 30 January 2028
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 293
Sex All
Age 18- 99
Therapy No

Trial Details

MicroDep is an investigator-initiated trial evaluating the safety and efficacy of low doses of psilocybin as a treatment for depression of moderate severity. We aim to recruit 293 participants to a 6week randomised, placebo controlled trial comprising 11 dosing sessions. Participants will be assessed at baseline, at week 6, and at 1-week and 1-month followup. The primary outcome measure will be the GRID-Hamilton Depression Rating Scale. Secondary outcomes include psychological measures, neurophysiological measures, and omics-based biomarkers. There will be a neuroimaging substudy that will investigate markers of neuroplasticity in 80 participants. We hypothesise that low doses of psilocybin administered over a 6 week period will be superior to placebo in improving clinical outcomes in moderate depression. If we find evidence of efficacy in the main stage, participants randomised to the placebo condition will be offered the opportunity to repeat the intervention with the active drug. Trial website

Trial Number ACTRN12623001064695

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

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