Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults

This randomised, double-blind, placebo-controlled trial (n=0, withdrawn) aimed to assess the efficacy of micro-dosed psilocybin (PSIL428) in reducing anxiety and/or depression levels in adults.

The Wake Network, Inc. conducted this study to investigate the effectiveness of a 16-week treatment with PSIL428 on patient-reported anxiety levels in otherwise healthy individuals suffering from depression and/or anxiety symptoms. Anxiety disorders affect an estimated 275 million people worldwide, with COVID-19 exacerbating new diagnoses and pre-existing conditions globally. While full-dose psilocybin has shown efficacy in treating anxiety and depression, its acute effects can incapacitate patients. Micro-dosing, however, has gained popularity for potentially improving mood and well-being without perceptual changes.

This novel trial was designed as a randomised, double-blind, placebo-controlled study to establish the safety and anxiolytic efficacy of PSIL428, a micro-dosed psilocybin regimen (2-5% of a full therapeutic dose), in adults with depression or anxiety. Participants were to be monitored for changes in anxiety and/or depression levels using the Beck Anxiety Inventory and Beck Depression Inventory forms bi-weekly over 16 weeks.

PSIL428 is an experimental intervention containing botanically derived psilocybin, administered in micro-doses to mitigate acute adverse effects associated with full therapeutic doses. The trial aimed to adhere to ethical guidelines, including obtaining informed consent and ensuring participant safety.

However, this study was withdrawn due to Good Clinical Practice violations from the sponsors. Despite its potential to contribute to the understanding of micro-dosed psilocybin’s therapeutic effects, the trial’s withdrawal halted further investigation into its efficacy and safety in reducing anxiety and depression levels.

Topic Anxiety Depression
Compound Psilocybin
Country Jamaica
Visit trial
Status Withdrawn
Results Published No
Start date 15 September 2022
End date 31 August 2023
Phase Phase II
Design Blinded
Type Interventional
Generation Third
Participants 0
Sex All
Age 18- 80
Therapy No

Trial Details

To investigate the efficacy of a 16 week treatment with PSIL428 patient reported anxiety levels in otherwise healthy individuals suffering from depression and or anxiety symptoms.

NCT Number NCT04989972

Sponsors & Collaborators

Wake
Wake are a biosciences company manufacturing and exploring psilocybin for treating mental health disorders. Through their genomics project, they hope to enhance the safety of psilocybin.

Data attribution

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