An Investigation of Psilocybin on Behavioural and... — Clinical Trial Details

Participants

Ages

18 – 50

Sexes

Male & Female

BMI

18.3 - +

Psychosis History

Inclusion Criteria

Inclusion Criteria:
1. 18 to 50 years of age
2. BMI > 18.3
3. Diagnosis of Fragile X syndrome with a molecular genetic confirmation of the full FMR1 mutation (>200 CGG repeats) or other loss of function mutations of the FMR1 gene (SNVs and deletions) based on evidence provided by caregiver from prior assessment
4. IQ between 40 and 85 points as reported by caregiver based on prior assessment
5. Subject has the ability to understand and provides voluntary, written, informed consent to participate in the study
Or,
For subjects who are not their own legal guardian, or do not have the capacity to provide informed consent, subject's parent/legal authorized guardian is able to understand and sign an informed consent form to participate in the study.
6. Caregiver (parent, guardian, or other legally authorized representative) who is willing to participate in the whole study and provides informed consent
7. Subject is able to swallow tablets and capsules
8. Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure or have been post-menopausal for at least 1 year prior to screening
Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include abstinence, hormonal contraceptives, double-barrier method, intrauterine devices, vasectomy of partner at least 6 months prior to screening, or agreement to use contraception if planning on changing to heterosexual partner(s).

Exclusion Criteria

Exclusion Criteria:
1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
3. 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
4. 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
5. 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
6. Have any of the following cardiovascular conditions: coronary artery disease, congenital long QT 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
7. 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
8. 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
9. Reported history of moderate to severe hepatic impairment
10. Type I or insulin-dependent Type II diabetes
11. 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
12. Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder in the past 12 months
13. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
14. 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

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Psilocybin 1.5 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators