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WithdrawnPhase 2

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

NCT04989972 · Wake Network, Inc.

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in Beck Anxiety Inventory BAI

    Measured over Screening to week 16

  • Changes in Beck Depression Inventory 02 - BDI-II

    Measured over screening to week 16

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 80 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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; * Not of child bearing potential, which is defined as females who have had hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with 1 year since last menstruation) OR * Female participants of childbearing potential must agree to 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. Acceptable methods of birth control include: * Hormonal contraceptives; oral, hormone patch (Ortho Evra), vaginal ring (NuvaRing), injectable (Depo-Provera, Lunelle), or hormone implant (Norplant System) * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner (shown successful as per appropriate follow-up); * Willing to maintain current levels of activity throughout the study; * Healthy as determined by self-report and medical history; * Willingness to complete all study visits and requirements associated with the study; * Has access to a computer, tablet, or smart phone with internet connection; sufficiently comfortable with using app-based technology for data gathering; * Has given voluntary, written, informed consent to participate in the study. Exclusion Criteria * Individuals who are pregnant, breastfeeding, or planning to become pregnant. * Individuals with psychotic disorders including schizophrenia; bipolar disorder. personality disorder. Participants with 1st-degree relatives with related psychotic disorders. * Alcohol or drug abuse within the last 6 months that meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. * Participation in a clinical research study within 30 days of enrollment. * Allergy or sensitivity to study product ingredients. * Clinically significant abnormal laboratory results at screening. * Unstable medical conditions as assessed by the Principal Investigator. * Individuals who are cognitively impaired and/or unable to give informed consent. * Any other condition which in the Principal Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant. * Individuals who have taken a psychedelic drug (Psilocybin, DMT, Peyote, Ayahuasca, Ibogaine, LSD, Ketamine) within 60 days of screening.

Where

1 study site

FacilityCityRegionCountry
FMS Department of PsychiatryKingstonJamaica

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04989972 on ClinicalTrials.gov →

Last updated in the registry 2022-06-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance