Trials Sponsors Conditions Drugs Pricing

Conditions

Fragile X Syndrome Behavior Cognitive Dysfunction

Keywords

Fragile X SyndromeBehaviorCognitive SymptomsPsilocybinMicrodose

Outcome Measures

Primary Outcomes (8)

Retention rate associated with 10 participants progressing to study completion.
Study completion is defined as completing the 28-day treatment period and the final in-clinic study visit.
baseline to day 28
Compliance with study dosing regimen as measured by the Visual Analogue Scale for Dosing (VAS-D).
Participants will be monitored for compliance using electronic compliance checks via the remote patient reported outcomes system through recording consumption in the treatment diary. Participants and caregivers will receive daily notifications via their preferred format (i.e., email, text) during agreed upon dosage windows. Notification will include a reminder to complete a post-dosage Visual Analogue Scale for Dosing (VAS-D) to monitor for any side effects which can be submitted electronically. Failure to complete the VAS-D within the day of dosing will trigger a call from study personnel to the participant in order to do a compliance check. Study personnel will note any deviations and all points of contact with participants regarding compliance checks.
baseline to day 28

Study Arms (1)

Psilocybin, 1.5 mg

EXPERIMENTAL

Participants will take one capsule containing 1.5 mg psilocybin with a glass of water every other day for a period of 28 days. Dosing schedule will be same for all participants with the drug taken at days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and no treatment taken on alternating days. No subject shall be provided with more than five capsules (7.5mg psilocybin) at any one time to prevent diversion to the illicit market. If a dose is missed, participants are instructed to skip that dose and continue with their regularly scheduled medications. Participants are not to take \>1 capsule per day.

Drug: Psilocybin, 1.5 mg

Interventions

Psilocybin, 1.5 mgDrug

Blister packs will contain five capsules of the study drug, Psilocybin 1.5mg. Subjects will be given blister packs with weekly doses at each visit including baseline (day 1), day 8, day 15, day 21, and day 28. Weekly blister packs will contain five doses (1-2 extra capsules depending on the week) to accommodate for flexibility in scheduling. Unused and open packages will be returned to study staff at each visit after baseline.

Psilocybin, 1.5 mg

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

to 50 years of age
BMI \> 18.3

Sponsors & Collaborators

KGK Science Inc.
Industrycollaborator
Nova Mentis Life Science Corp
Industrylead

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

MeSH Terms

Conditions

Fragile X SyndromeBehaviorCognitive DysfunctionNeurobehavioral Manifestations

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurologic ManifestationsNervous System DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

David Crowley, MD
KGK Science Inc.
PRINCIPAL INVESTIGATOR
Marvin Hausman, MD
Nova Mentis Life Science Corp
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 27, 2023

Study Start

March 28, 2023

Actual (reported)

Primary Completion

May 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
Urine drug test containing non-prescribed drugs of abuse (non-prescribed opioids, benzodiazepines, amphetamines, phencyclidine, cocaine) at screening and day of first treatment. Urine cannabinoid concentrations \>50 ng/ml will suggest heavy marijuana use and will be a threshold for excluding potential subjects
Having uncontrolled hypertension defined as an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, with at least 4 BP assessments completed.
Have any of the following cardiovascular conditions: coronary artery disease, congenital long QT (time from the start of the Q wave to the end of the T wave) syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition
Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
Subjects with a history of seizure disorder except those who are currently receiving treatment with anti-epileptics and have been seizure-free for 3 months preceding screening or have been seizure-free for 3 years if not currently receiving anti-epileptics.
Reported history of moderate to severe hepatic impairment
Type I or insulin-dependent Type II diabetes
Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder
Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder in the past 12 months
Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
Medical illness based on physical examination, ECG and routine testing that may complicate cardiovascular safety or drug metabolism or excretion, such as metabolic disease, severe cardiac disease, or kidney or liver failure as assessed by the QI. QI assessments will be based on clinical history provided by caregivers and/or physicians. Any participant requiring further assessment will be referred accordingly or excluded by the QI on a case-by-case basis.\*
Current or history of any significant diseases of the gastrointestinal tract, exceptions to be determined by the QI
+4 more criteria

Study Stopped

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Study Arms (1)

Psilocybin, 1.5 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Secondary Outcomes (19)

Other Outcomes (8)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Study Arms (1)

Psilocybin, 1.5 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Secondary Outcomes (19)

Other Outcomes (8)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations