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Trial record 2 of 3 for:    psilocybin | Withdrawn Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04989972
Recruitment Status : Withdrawn (GCP VIOLATIONS FROM THE SPONSORS)
First Posted : August 4, 2021
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI
Information provided by (Responsible Party):
Wake Network, Inc.

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.

Condition or disease Intervention/treatment Phase
Anxiety and Depression Drug: PSIL428 Dietary Supplement: Oyster mushroom Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
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, 2022
Estimated Primary Completion Date : June 20, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Intervention arm
participants will take the active intervention PSIL428
Drug: PSIL428
1 mg of psilocybin

Experimental: placebo arm
participants will take the intervention 1 mg Oyster mushrooms
Dietary Supplement: Oyster mushroom
1 mg of oyster mushroom

Experimental: open label
all participants will take the active intervention PSIL428
Drug: PSIL428
1 mg psilocybin




Primary Outcome Measures :
  1. 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


  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. The incidence of adverse events [ Time Frame: Screening to 16 weeks ]
    The number of reported cases of adverse events

  6. The severity of adverse events [ Time Frame: Screening to 16 weeks ]
    Adverse events which range from mild,moderate, severe and lethal

  7. Incidence of abnormal blood pressure [ Time Frame: Screening to 16 weeks ]
    Blood pressure which is consistently above and below120/80

  8. Incidence of abnormal heart rate [ Time Frame: Screening to 16 weeks ]
    The incidence of atrial fibrillation, supraventricular tachycardia or bradycardia

  9. incidence of irregular heart rate [ Time Frame: Screening to 16 weeks ]
    incidence of arrhythmias

  10. 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

  11. Change in the number of steps [ Time Frame: Screening to Week 16 ]
    Wearable and or mobile devices

  12. Changes in concomitant medication [ Time Frame: Screening to 16 weeks ]
    Recently prescribed medication

  13. Changes in volume of Alcohol [ Time Frame: screening to 16 weeks ]
    self reports

  14. Changes in the number of cigarettes [ Time Frame: screening to 16 weeks ]
    self reports

  15. Changes in the number of cannabis joints [ Time Frame: Screening to 16 weeks ]
    Self reports

  16. Changes in other over the counter medication [ Time Frame: Screening to 16 weeks ]
    Self Reports

  17. Changes in Estradiol [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values

  18. Changes in Testosterone [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile vales

  19. Changes in Cortisol [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values

  20. Changes in Progesterone [ Time Frame: Screening to 16 weeks ]
    Salivary panel profiles values

  21. Changes in Melatonin [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values

  22. Changes in DHEA (Dehydroepiandrosterone) [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values

  23. Changes in DHT(Dihydrotestosterone) [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values

  24. Changes in Androstenedione [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values

  25. Changes in Estrone [ Time Frame: Screening to 16 weeks ]
    Salivary panel profile values



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04989972


Locations
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Jamaica
FMS Department of Psychiatry
Kingston, Jamaica
Sponsors and Collaborators
Wake Network, Inc.
Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI
Investigators
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Principal Investigator: Roger Gibson Faculty of Medical Sciences UWI Mona
Study Director: Sharon White Wake Network, Inc.
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Responsible Party: Wake Network, Inc.
ClinicalTrials.gov Identifier: NCT04989972    
Other Study ID Numbers: ECP242-19/20
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be made available through publications and conference presentations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders