A Phase 2 interventional study of PSIL428 and Oyster mushroom in Anxiety and Depression, sponsored by Wake Network, Inc.. Withdrawn at 1 site in Jamaica. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Wake Network, Inc. · Phase 2, Interventional, and Treatment
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.
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.
This will be a novel randomized, double-blind, placebo-controlled study aimed at establishment of safety and anxiolytic efficacy of psilocybin PSIL428 administered in a micro-dosing regimen (2-5% of a full therapeutic dose) to adults suffering from depression or anxiety.
The primary outcome of this study is the change in anxiety and/or depression levels from screening to week 16. Participant anxiety levels will be monitored through Beck Anxiety inventory, depression levels - through Beck Depression Inventory forms on a bi-weekly basis across the course of the study.
Study Drug PSIL428 is an experimental intervention and the active ingredient psilocybin is botanically derived. Similar interventions are currently undergoing Phase IIb/III clinical trials in international jurisdictions. It is being assessed for treatment of depressive disorders. Typically psilocybin used in full therapeutic doses associated with significant acute adverse effects. The proposed trial would utilize psilocybin in different dosing regimen - as micro-dosing - ingesting of sub-perceptual doses of the drug equal to 2-10% of the full dose. The micro-dosing practice is gaining significant popularity world-wide, however evidence-based data around it is minimal. Risks and benefits associated with the trial are not definitively established, however existing pre-clinical and clinical data around full-dose use of the drug carries a favorable risk-benefit potential.
The trial will be conducted in accordance with the most recently acceptable version of the Declaration of Helsinki, Good Clinical Practice (GCP) according to International Conference on Harmonization (ICH) guidelines, and applicable Standard Operating Procedures (SOPs). The trial will be conducted under a protocol reviewed and approved by an IRB; the trial will be conducted by scientifically and medically qualified persons; the benefits of the study are in proportion to the risks; the rights and welfare of the subjects will be respected; each subject will give his or her written informed consent before any protocol-driven tests or evaluations are performed.
The investigators are responsible for obtaining informed consent in adherence to GCP and according to applicable regulations prior to entering the subject into the trial.
A positive change in Beck Anxiety and/or Beck Depression numeric levels between PSIL428 and placebo groups will mark our primary outcome achievement of confirming beneficial effects of micro-dose-administered psilocybin on study participants' overall anxiety and/or depression levels
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →This is the only study on the registry with Wake Network, Inc. as lead sponsor.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants will take the active intervention PSIL428
Drug: PSIL428
participants will take the intervention 1 mg Oyster mushrooms
Dietary Supplement: Oyster mushroom
all participants will take the active intervention PSIL428
Drug: PSIL428
1 mg of psilocybin
1 mg of oyster mushroom
1 mg psilocybin
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
Time frame: 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
Time frame: screening to week 16
Change in the European Quality of life 5 dimensions- EQ-5D
changes between the intervention PSIL-428 and placebo groups for mobility, self-care, pain \& discomfort, usual activities and anxiety \& depression
Time frame: screening to week 16
Cognitive flexibility, using the Stroop Color & Word Test (SCWT)
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
Time frame: Screening to week 16
Changes in resilience using the Brief Resiliency Scale
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
Time frame: Screening to 16 weeks
Measurement of higher level cognitive processes using the Wisconsin Card Sorting Test
Uses two card packs, having 4 stimulus cards and 64 response cards measures attention, perseverance , abstract thinking and set shifting.
Time frame: screen to 16 weeks
The incidence of adverse events
The number of reported cases of adverse events
Time frame: Screening to 16 weeks
The severity of adverse events
Adverse events which range from mild,moderate, severe and lethal
Time frame: Screening to 16 weeks
Incidence of abnormal blood pressure
Blood pressure which is consistently above and below120/80
Time frame: Screening to 16 weeks
Incidence of abnormal heart rate
The incidence of atrial fibrillation, supraventricular tachycardia or bradycardia
Time frame: Screening to 16 weeks
incidence of irregular heart rate
incidence of arrhythmias
Time frame: Screening to 16 weeks
incidence of suicidal ideation using the Columbian Suicide Severity Rating Scale
Measures Suicidal Ideation items 1-5; Suicidal Behavior 6-10 and both Suicidal Ideation and Behavior Items 1-10
Time frame: Screening to 16 weeks
Change in the number of steps
Wearable and or mobile devices
Time frame: Screening to Week 16
Changes in concomitant medication
Recently prescribed medication
Time frame: Screening to 16 weeks
Changes in volume of Alcohol
self reports
Time frame: screening to 16 weeks
Changes in the number of cigarettes
self reports
Time frame: screening to 16 weeks
Changes in the number of cannabis joints
Self reports
Time frame: Screening to 16 weeks
Changes in other over the counter medication
Self Reports
Time frame: Screening to 16 weeks
Changes in Estradiol
Salivary panel profile values
Time frame: Screening to 16 weeks
Changes in Testosterone
Salivary panel profile vales
Time frame: Screening to 16 weeks
Changes in Cortisol
Salivary panel profile values
Time frame: Screening to 16 weeks
Changes in Progesterone
Salivary panel profiles values
Time frame: Screening to 16 weeks
Changes in Melatonin
Salivary panel profile values
Time frame: Screening to 16 weeks
Changes in DHEA (Dehydroepiandrosterone)
Salivary panel profile values
Time frame: Screening to 16 weeks
Changes in DHT(Dihydrotestosterone)
Salivary panel profile values
Time frame: Screening to 16 weeks
Changes in Androstenedione
Salivary panel profile values
Time frame: Screening to 16 weeks
Changes in Estrone
Salivary panel profile values
Time frame: Screening to 16 weeks
Plan to share: No — The data will be made available through publications and conference presentations
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for Jun 2023, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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