Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Wake Network, Inc.
- Locations
- 1
- Primary Endpoint
- Changes in Beck Anxiety Inventory BAI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
double blind
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention arm
participants will take the active intervention PSIL428
Intervention: PSIL428 (Drug)
placebo arm
participants will take the intervention 1 mg Oyster mushrooms
Intervention: Oyster mushroom (Dietary Supplement)
open label
all participants will take the active intervention PSIL428
Intervention: PSIL428 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cognitive flexibility, using the Stroop Color & Word Test (SCWT)(Screening to week 16)
- 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)
- Change in the European Quality of life 5 dimensions- EQ-5D(screening to week 16)
- Changes in resilience using the Brief Resiliency Scale(Screening to 16 weeks)
- Incidence of abnormal heart rate(Screening to 16 weeks)
- The severity of adverse events(Screening to 16 weeks)
- Incidence of abnormal blood pressure(Screening to 16 weeks)
- incidence of irregular heart rate(Screening to 16 weeks)
- Changes in the number of cannabis joints(Screening to 16 weeks)
- Changes in other over the counter medication(Screening to 16 weeks)
- Changes in Testosterone(Screening to 16 weeks)
- Changes in Progesterone(Screening to 16 weeks)
- Changes in Melatonin(Screening to 16 weeks)
- Changes in DHEA (Dehydroepiandrosterone)(Screening to 16 weeks)
- Changes in DHT(Dihydrotestosterone)(Screening to 16 weeks)
- Changes in Androstenedione(Screening to 16 weeks)
- incidence of suicidal ideation using the Columbian Suicide Severity Rating Scale(Screening to 16 weeks)
- Changes in volume of Alcohol(screening to 16 weeks)
- Change in the number of steps(Screening to Week 16)
- Changes in concomitant medication(Screening to 16 weeks)
- Changes in the number of cigarettes(screening to 16 weeks)
- Changes in Estradiol(Screening to 16 weeks)
- Changes in Cortisol(Screening to 16 weeks)
- Changes in Estrone(Screening to 16 weeks)