Sponsor: Wake Network, Inc.

Collaborator: Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI

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Brief Summary:

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.

Detailed Description:

Randomized, double-blind, placebo-controlled study assessing the efficacy of micro-dosed psilocybin on reducing anxiety and/or depression levels in adults. The effectiveness of full dose psilocybin for treatment of anxiety and depression has been shown in several clinical trials. While there is significant evidence of clinical efficacy of full dose psilocybin, acute effects of the dose result in a significant impairment – perceptual and sensory distortions incapacitating the patient for the duration of drug activity. Recent work suggests while not producing perceptual changes, micro-dosing may indeed be associated with improved mood and enhanced well-being. The practice of micro-dosing is gaining popularity in the general population, while clinical data on its safety and efficacy is lacking.

This will be a novel randomized, double-blind, placebo-controlled study aimed at establishment of safety and anxiolytic efficacy of psilocybin PSIL428 administered in a micro-dosing regimen (2-5% of a full therapeutic dose) to adults suffering from depression or anxiety.

The primary outcome of this study is the change in anxiety and/or depression levels from screening to week 16. Participant anxiety levels will be monitored through Beck Anxiety inventory, depression levels – through Beck Depression Inventory forms on a bi-weekly basis across the course of the study.

Study Design:

Study Type:Interventional (Clinical Trial)
Estimated Enrollment 120 participants
Intervention Model:Parallel Assignment
Intervention Model Description:The research design has a parallel design for the first 8 weeks and a open label single group study for the last 8 weeks
Masking:Double (Participant, Investigator)
Masking Description:double blind
Primary Purpose:Treatment
Official Title:Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults
Estimated Study Start Date:September 15, 2021
Estimated Primary Completion Date:June 20, 2022
Estimated Study Completion Date:August 31, 2022

Inclusion Criteria:

  • Experiencing persistent anxiety and/or depression symptoms
  • Scoring between 10-20 on BAI and/or between 15-25 on BDI-II
  • Females and males with the minimum age of 18 at screening;
  • Heterosexual females of childbearing potential must use a medically approved method of birth control and have a negative urine pregnancy test result, prior to enrollment. All hormonal birth controls require a minimum stability of three months and remain consistent throughout the study.

Content retrieved from https://clinicaltrials.gov/ (NCT number): NCT04989972

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