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

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Network, Inc.
• Collaborators: Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI; The University of The West Indies

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.