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

NCT04989972 | Withdrawn Phase 2 DMC

• 1 other identifier: ECP242-19/20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Depression

Outcome Measures

Primary Outcomes (2)

• Changes in Beck Anxiety Inventory BAI

  Measures 21 items in physical and cognitive anxiety ranges 0-7 mild, to 26-63 severe Questionnaire BDI-11

  Screening to week 16

• Changes in Beck Depression Inventory 02 - BDI-II

  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

  screening to week 16

Secondary Outcomes (25)

• Change in the European Quality of life 5 dimensions- EQ-5D

  screening to week 16

• Cognitive flexibility, using the Stroop Color & Word Test (SCWT)

  Screening to week 16

• Changes in resilience using the Brief Resiliency Scale

  Screening to 16 weeks

• Measurement of higher level cognitive processes using the Wisconsin Card Sorting Test

  screen to 16 weeks

• The incidence of adverse events

  Screening to 16 weeks

Study Arms (3)

Intervention arm

EXPERIMENTAL

participants will take the active intervention PSIL428

Drug: PSIL428

placebo arm

EXPERIMENTAL

participants will take the intervention 1 mg Oyster mushrooms

Dietary Supplement: Oyster mushroom

open label

EXPERIMENTAL

all participants will take the active intervention PSIL428

Drug: PSIL428

Interventions

PSIL428 DRUG

1 mg of psilocybin

Intervention arm

Oyster mushroom DIETARY_SUPPLEMENT

1 mg of oyster mushroom

placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Network, Inc.: lead
• Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI: collaborator

Study Sites (1)

FMS Department of Psychiatry

Kingston, Jamaica

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

pleurotolysin B, oyster mushroom

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Roger Gibson

  Faculty of Medical Sciences UWI Mona

  PRINCIPAL INVESTIGATOR

• Sharon White

  Wake Network, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The research design has a parallel design for the first 8 weeks and a open label single group study for the last 8 weeks

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 4, 2021
• Study Start: September 15, 2022
• Primary Completion: June 20, 2023
• Study Completion: August 31, 2023
• Last Updated: June 30, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)