Clinical TrialAnxiety DisordersPsilocybinPlaceboPsilocybinWithdrawn

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

This randomised, double-blind, placebo-controlled trial (n=0, withdrawn) aimed to assess the efficacy of micro-dosed psilocybin (PSIL428) in reducing anxiety and/or depression levels in adults.

Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, parallel 16-week study (first 8 weeks double-blind PSIL428 vs placebo; weeks 9–16 open-label PSIL428) evaluating micro-dosed psilocybin (PSIL428, 1 mg) for adults with anxiety and/or depression symptoms.

Primary outcome is change in anxiety and/or depression from baseline to week 16 measured by Beck Anxiety Inventory and Beck Depression Inventory (bi-weekly); safety assessed via labs and adverse events.

Study Arms & Interventions

PSIL428 (microdose)

experimental

Micro-dosed psilocybin (PSIL428), 1 mg, double-blind intervention arm (weeks 1–8).

Interventions

  • Psilocybin1 mg
    via Oral

    Microdose regimen; 1 mg psilocybin (per registry)

Placebo (oyster mushroom)

inactive

Placebo comparator using oyster mushroom 1 mg (double-blind).

Interventions

  • Placebo1 mg
    via Oral

    Oyster mushroom 1 mg used as placebo control

Open-label PSIL428

experimental

Open-label single-group PSIL428 phase (weeks 9–16) where all participants receive PSIL428.

Interventions

  • Psilocybin1 mg
    via Oral

    Open-label PSIL428 1 mg during weeks 9–16

Participants

Ages
18 – 80
Sexes
Male & Female

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.

Study Details

Locations

FMS Department of Psychiatry — Kingston, Jamaica

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