Anxiety and DepressionPhase 2NCT04989972
Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults
A Phase 2 study testing PSIL428 and Oyster mushroom in people with Anxiety and Depression, run by Wake Network, Inc. at 1 site in Jamaica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety and Depression
- What is being tested?
- PSIL428 and Oyster mushroom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJamaica
- Study dates
- 15 Sep 2022to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults
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.
Read the 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.
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
- Conditions
- Anxiety and Depression
- Being tested
- PSIL428, Oyster mushroom
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSIL428Drug
1 mg of psilocybin
Oyster mushroomDietary supplement
1 mg of oyster mushroom
PSIL428Drug
1 mg psilocybin
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | participants will take the active intervention PSIL428 Receives: Drug: PSIL428 |
| placebo arm | Experimental | participants will take the intervention 1 mg Oyster mushrooms Receives: Dietary Supplement: Oyster mushroom |
| open label | Experimental | all participants will take the active intervention PSIL428 Receives: Drug: PSIL428 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: screening to week 16
Secondary outcomes (25)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: screen to 16 weeks
The incidence of adverse events
The number of reported cases of adverse events
Measured: Screening to 16 weeks
The severity of adverse events
Adverse events which range from mild,moderate, severe and lethal
Measured: Screening to 16 weeks
Incidence of abnormal blood pressure
Blood pressure which is consistently above and below120/80
Measured: Screening to 16 weeks
Incidence of abnormal heart rate
The incidence of atrial fibrillation, supraventricular tachycardia or bradycardia
Measured: Screening to 16 weeks
incidence of irregular heart rate
incidence of arrhythmias
Measured: 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
Measured: Screening to 16 weeks
Change in the number of steps
Wearable and or mobile devices
Measured: Screening to Week 16
Changes in concomitant medication
Recently prescribed medication
Measured: Screening to 16 weeks
Changes in volume of Alcohol
self reports
Measured: screening to 16 weeks
Changes in the number of cigarettes
self reports
Measured: screening to 16 weeks
Changes in the number of cannabis joints
Self reports
Measured: Screening to 16 weeks
Changes in other over the counter medication
Self Reports
Measured: Screening to 16 weeks
Changes in Estradiol
Salivary panel profile values
Measured: Screening to 16 weeks
Changes in Testosterone
Salivary panel profile vales
Measured: Screening to 16 weeks
Changes in Cortisol
Salivary panel profile values
Measured: Screening to 16 weeks
Changes in Progesterone
Salivary panel profiles values
Measured: Screening to 16 weeks
Changes in Melatonin
Salivary panel profile values
Measured: Screening to 16 weeks
Changes in DHEA (Dehydroepiandrosterone)
Salivary panel profile values
Measured: Screening to 16 weeks
Changes in DHT(Dihydrotestosterone)
Salivary panel profile values
Measured: Screening to 16 weeks
Changes in Androstenedione
Salivary panel profile values
Measured: Screening to 16 weeks
Changes in Estrone
Salivary panel profile values
Measured: Screening to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start15 Sep 2022 (estimated)
- Primary completion20 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Why it stopped: GCP VIOLATIONS FROM THE SPONSORS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research design has a parallel design for the first 8 weeks and a open label single group study for the last 8 weeks
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Network, Inc.
- Sponsor type
- Research network
- Collaborators
- Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI
- Responsible party
- Sponsor
- Investigators
- Roger Gibson, Principal investigator, Faculty of Medical Sciences UWI MonaSharon White, Study director, Wake Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989972
- Sponsor's protocol ID
- ECP242-19/20
- Status last verified
- Jun 2021
- First submitted
- 12 Jul 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be made available through publications and conference presentations
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults
- ClinicalTrials.gov ID
- NCT04989972
- Acronym / sponsor ID
- ECP242-19/20
- Conditions
- Anxiety and Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: GCP VIOLATIONS FROM THE SPONSORS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Network, Inc.Research network
- Collaborators
- Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The research design has a parallel design for the first 8 weeks and a open label single group study for the last 8 weeks
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: PSIL428participants will take the active intervention PSIL428 |
| placebo arm | Experimental | Dietary Supplement: Oyster mushroomparticipants will take the intervention 1 mg Oyster mushrooms |
| open label | Experimental | Drug: PSIL428all participants will take the active intervention PSIL428 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSIL4281 mg of psilocybin | Drug | Intervention arm |
| Oyster mushroom1 mg of oyster mushroom | Dietary supplement | placebo arm |
| PSIL4281 mg psilocybin | Drug | open label |
Primary outcome
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
25 secondary outcomes
Change in the European Quality of life 5 dimensions- EQ-5D
Time frame: screening to week 16
Cognitive flexibility, using the Stroop Color & Word Test (SCWT)
Time frame: Screening to week 16
Changes in resilience using the Brief Resiliency Scale
Time frame: Screening to 16 weeks
Measurement of higher level cognitive processes using the Wisconsin Card Sorting Test
Time frame: screen to 16 weeks
The incidence of adverse events
Time frame: Screening to 16 weeks
The severity of adverse events
Time frame: Screening to 16 weeks
Incidence of abnormal blood pressure
Time frame: Screening to 16 weeks
Incidence of abnormal heart rate
Time frame: Screening to 16 weeks
incidence of irregular heart rate
Time frame: Screening to 16 weeks
incidence of suicidal ideation using the Columbian Suicide Severity Rating Scale
Time frame: Screening to 16 weeks
Change in the number of steps
Time frame: Screening to Week 16
Changes in concomitant medication
Time frame: Screening to 16 weeks
Changes in volume of Alcohol
Time frame: screening to 16 weeks
Changes in the number of cigarettes
Time frame: screening to 16 weeks
Changes in the number of cannabis joints
Time frame: Screening to 16 weeks
Changes in other over the counter medication
Time frame: Screening to 16 weeks
Changes in Estradiol
Time frame: Screening to 16 weeks
Changes in Testosterone
Time frame: Screening to 16 weeks
Changes in Cortisol
Time frame: Screening to 16 weeks
Changes in Progesterone
Time frame: Screening to 16 weeks
Changes in Melatonin
Time frame: Screening to 16 weeks
Changes in DHEA (Dehydroepiandrosterone)
Time frame: Screening to 16 weeks
Changes in DHT(Dihydrotestosterone)
Time frame: Screening to 16 weeks
Changes in Androstenedione
Time frame: Screening to 16 weeks
Changes in Estrone
Time frame: Screening to 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No. The data will be made available through publications and conference presentations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Gibson principal investigator
Faculty of Medical Sciences UWI Mona
Sharon White study director
Wake Network, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PSIL428 and Oyster mushroom in people with Anxiety and Depression, run by Wake Network, Inc. at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Beck Anxiety Inventory BAI (time frame: Screening to week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.