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

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ClinicalTrials.gov Identifier: NCT04989972
Recruitment Status : Not yet recruiting
First Posted : August 4, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborator:
Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI
Information provided by (Responsible Party):
Wake Network, Inc.

Tracking Information
First Submitted Date  ICMJE July 12, 2021
First Posted Date  ICMJE August 4, 2021
Last Update Posted Date August 26, 2021
Estimated Study Start Date  ICMJE September 15, 2021
Estimated Primary Completion Date June 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2021)
  • Changes in Beck Anxiety Inventory BAI [ Time Frame: Screening to week 16 ]
    Measures 21 items in physical and cognitive anxiety ranges 0-7 mild, to 26-63 severe Questionnaire BDI-11
  • Changes in Beck Depression Inventory 02 - BDI-II [ Time Frame: screening to week 16 ]
    Measures 21 items in the presence and severity of depressive symptoms 0-9 no depression, 10 -18 mild depression, 19-29 moderate to severe depression
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2021)
  • Change in the European Quality of life 5 dimensions- EQ-5D [ Time Frame: screening to week 16 ]
    changes between the intervention PSIL-428 and placebo groups for mobility, self-care, pain & discomfort, usual activities and anxiety & depression
  • Cognitive flexibility, using the Stroop Color & Word Test (SCWT) [ Time Frame: Screening to week 16 ]
    Changes in cognition between the PSIL-428 and placebo groups in the reading of words as compared to identifying & naming colors. A stopwatch is used and the test-taker reads color words or names ink colors from different pages as quickly as possible. An interference score, cognitive flexibility, creativity and reaction to cognitive pressure are measured
  • Changes in resilience using the Brief Resiliency Scale [ Time Frame: Screening to 16 weeks ]
    assesses the ability of the individual to bounce back or recover from stress a score of one means low resiliency and a score of 5 means high resiliency
  • Measurement of higher level cognitive processes using the Wisconsin Card Sorting Test [ Time Frame: screen to 16 weeks ]
    Uses two card packs, having 4 stimulus cards and 64 response cards measures attention, perseverance , abstract thinking and set shifting.
  • The incidence of adverse events [ Time Frame: Screening to 16 weeks ]
    The number of reported cases of adverse events
  • The severity of adverse events [ Time Frame: Screening to 16 weeks ]
    Adverse events which range from mild,moderate, severe and lethal
  • Incidence of abnormal blood pressure [ Time Frame: Screening to 16 weeks ]
    Blood pressure which is consistently above and below120/80
  • Incidence of abnormal heart rate [ Time Frame: Screening to 16 weeks ]
    The incidence of atrial fibrillation, supraventricular tachycardia or bradycardia
  • incidence of irregular heart rate [ Time Frame: Screening to 16 weeks ]
    incidence of arrhythmias
  • incidence of suicidal ideation using the Columbian Suicide Severity Rating Scale [ Time Frame: Screening to 16 weeks ]
    Measures Suicidal Ideation items 1-5; Suicidal Behavior 6-10 and both Suicidal Ideation and Behavior Items 1-10
  • Change in the number of steps [ Time Frame: Screening to Week 16 ]
    Wearable and or mobile devices
  • Changes in concomitant medication [ Time Frame: Screening to 16 weeks ]
    Recently prescribed medication
  • Changes in volume of Alcohol [ Time Frame: screening to 16 weeks ]
    self reports
  • Changes in the number of cigarettes [ Time Frame: screening to 16 weeks ]
    self reports
  • Changes in the number of cannabis joints [ Time Frame: Screening to 16 weeks ]
    Self reports
  • Changes in other over the counter medication [ Time Frame: Screening to 16 weeks ]
    Self Reports
  • Changes in Estradiol [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
  • Changes in Testosterone [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile vales
  • Changes in Cortisol [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
  • Changes in Progesterone [ Time Frame: Screening to 16 weeks ]
    Salivary panel profiles values
  • Changes in Melatonin [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
  • Changes in DHEA (Dehydroepiandrosterone) [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
  • Changes in DHT(Dihydrotestosterone) [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
  • Changes in Androstenedione [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
  • Changes in Estrone [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults
Official Title  ICMJE Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults
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

Study summary:

The Institute for Health Metrics and Evaluation reported that Anxiety disorders currently affect an estimated 275 million people worldwide, about one in 13 people (7.3 percent).

COVID-19 has accelerated the rate of new anxiety diagnoses and exacerbated pre-existing diagnoses of anxiety in individuals worldwide.

The effectiveness of full dose psilocybin for treatment of anxiety and depression has been shown in a number of clinical trials. While there is a 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 Drug PSIL428 is an experimental intervention and the active ingredient psilocybin is botanically derived. Similar interventions are currently undergoing Phase IIb/III clinical trials in international jurisdictions. It is being assessed for treatment of depressive disorders. Typically psilocybin used in full therapeutic doses associated with significant acute adverse effects. The proposed trial would utilize psilocybin in different dosing regimen - as micro-dosing - ingesting of sub-perceptual doses of the drug equal to 2-10% of the full dose. The micro-dosing practice is gaining significant popularity world-wide, however evidence-based data around it is minimal. Risks and benefits associated with the trial are not definitively established, however existing pre-clinical and clinical data around full-dose use of the drug carries a favorable risk-benefit potential.

The trial will be conducted in accordance with the most recently acceptable version of the Declaration of Helsinki, Good Clinical Practice (GCP) according to International Conference on Harmonization (ICH) guidelines, and applicable Standard Operating Procedures (SOPs). The trial will be conducted under a protocol reviewed and approved by an IRB; the trial will be conducted by scientifically and medically qualified persons; the benefits of the study are in proportion to the risks; the rights and welfare of the subjects will be respected; each subject will give his or her written informed consent before any protocol-driven tests or evaluations are performed.

The investigators are responsible for obtaining informed consent in adherence to GCP and according to applicable regulations prior to entering the subject into the trial.

A positive change in Beck Anxiety and/or Beck Depression numeric levels between PSIL428 and placebo groups will mark our primary outcome achievement of confirming beneficial effects of micro-dose-administered psilocybin on study participants' overall anxiety and/or depression levels

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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
Condition  ICMJE Anxiety and Depression
Intervention  ICMJE
  • Drug: PSIL428
    1 mg of psilocybin
  • Dietary Supplement: Oyster mushroom
    1 mg of oyster mushroom
  • Drug: PSIL428
    1 mg psilocybin
Study Arms  ICMJE
  • Experimental: Intervention arm
    participants will take the active intervention PSIL428
    Intervention: Drug: PSIL428
  • Experimental: placebo arm
    participants will take the intervention 1 mg Oyster mushrooms
    Intervention: Dietary Supplement: Oyster mushroom
  • Experimental: open label
    all participants will take the active intervention PSIL428
    Intervention: Drug: PSIL428
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date June 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olga Chernoloz 647.237.5005 ochernoloz@wake.net
Contact: Nick Murray 604.356.6425 nick@wake.net
Listed Location Countries  ICMJE Jamaica
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04989972
Other Study ID Numbers  ICMJE ECP242-19/20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will be made available through publications and conference presentations
Responsible Party Wake Network, Inc.
Study Sponsor  ICMJE Wake Network, Inc.
Collaborators  ICMJE Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI
Investigators  ICMJE
Principal Investigator: Roger Gibson Faculty of Medical Sciences UWI Mona
Study Director: Sharon White Wake Network, Inc.
PRS Account Wake Network, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP