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Psychedelic
Psilocybin for Fragile X Syndrome
Phase 2
Recruiting
Led By David Crowley, MD
Research Sponsored by Nova Mentis Life Science Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Fragile X syndrome with a molecular genetic confirmation of the full FMR1 mutation (>200 CGG repeats) or the other loss of function mutations of the FMR1 gene (SNVs and deletions of the gene) based on evidence provided by caregiver from prior assessment
18 to 50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 8, day 15, day 21, day 28
Awards & highlights
Study Summary
This trial seeks to explore if psilocybin can safely treat Fragile X Syndrome, which currently has no approved treatments. It hopes to improve diagnosis & therapeutic responses w/ biomarkers.
Who is the study for?
Adults aged 18-50 with Fragile X syndrome confirmed by genetic testing, able to swallow pills, and not planning pregnancy or using reliable birth control can join. They must have a BMI over 18.3 and an IQ between 40-85. Exclusions include uncontrolled high blood pressure, severe liver or heart conditions, certain mental health disorders, drug abuse, recent major surgery, or unstable medical conditions.Check my eligibility
What is being tested?
The trial is exploring the effects of low-dose psilocybin (1.5 mg) on behavior and cognitive symptoms in adults with Fragile X Syndrome. It aims to see if this treatment improves cognition, mood, behavior as well as biological markers related to brain function without causing hallucinations.See study design
What are the potential side effects?
While the study uses sub-hallucinogenic doses of psilocybin aiming for minimal side effects, potential risks may include mild gastrointestinal upset like nausea or diarrhea; short-term changes in mood or perception; headache; fatigue; and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Fragile X syndrome confirmed by genetic testing.
Select...
I am between 18 and 50 years old.
Select...
I cannot have children due to surgery or being post-menopausal for over a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 8, day 15, day 21, day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 8, day 15, day 21, day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence with completion of diaries monitoring participant and caregiver reported outcomes.
Adherence with completion of questionnaires monitoring participant and caregiver reported outcomes.
Compliance with study dosing regimen as measured by the Visual Analogue Scale for Dosing (VAS-D).
+5 moreSecondary outcome measures
Change from baseline in standardized measures of behavioral rigidity using the ratings of repetitive and stereotyped behaviors from the revised Repetitive Behavior Scale (RBS-R).
Change in standardized measures of empathy using the communication domain of the Vineland Adaptive Behavior Scales- Third Edition (VABS-3).
Change in standardized measures of empathy using the overall score on the Multifaceted Empathy Test for juveniles (MET-J).
+16 moreOther outcome measures
The incidence of clinically significant changes in blood pressure (BP).
The incidence of clinically significant changes in heart rate (HR).
The incidence of pre-emergent and post-emergent adverse events.
+5 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psilocybin, 1.5 mgExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Nova Mentis Life Science CorpLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Fragile X Syndrome
300 Patients Enrolled for Fragile X Syndrome
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,150 Total Patients Enrolled
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,743 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Fragile X syndrome confirmed by genetic testing.I am between 18 and 50 years old.I have a heart condition such as heart disease, heart attack, or abnormal heart rhythm.You have been diagnosed with a serious alcohol or drug problem in the past year according to specific guidelines.I plan to start or change my treatment during the study.I have a seizure history but have been seizure-free for 3 months on medication or 3 years without medication.I have Type I diabetes or insulin-dependent Type II diabetes.If you have used drugs that were not prescribed to you, like opioids, benzodiazepines, amphetamines, phencyclidine, or cocaine, you will not be able to participate. If your urine test shows high levels of marijuana, you may also be excluded.I do not have severe heart, liver, or kidney problems that could affect my treatment safety.I have no significant gastrointestinal diseases, or they are approved exceptions.My blood pressure is not controlled, but I've been on the same medication for 3 months.You weigh more than what is considered healthy for your height.You are allergic or sensitive to any of the ingredients in the experimental drug.I am not on medication that interacts badly with psilocybin.I have been diagnosed with a schizophrenia spectrum disorder, major depression with psychosis, or bipolar disorder.I haven't had major surgery in the last 3 months and don't plan any during the study.I am using or agree to use an approved birth control method if I can become pregnant.I have a history of serious liver problems.I haven't had a major heart problem in the last 6 months.I understand the study and agree to participate.You have any other health issues or habits that could make it difficult for you to take part in the study, or could be risky for you. Also, this study won't involve taking blood samples because it could be too stressful for the participants.My legal guardian can consent for me as I'm unable to.I can swallow pills.I cannot have children due to surgery or being post-menopausal for over a year.My blood pressure is often higher than 140/90 mmHg.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin, 1.5 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over the age of 40 eligible to participate in this experimental trial?
"This investigational study is enrolling individuals aged 18 and under 50."
Answered by AI
Does my profile meet the criteria for inclusion in this research program?
"In order to be accepted, candidates must demonstrate appropriate behaviour and fall within the 18-50 year age range. Spots are limited; only 10 participants will be taken into consideration."
Answered by AI
What is the scope of participation in this research endeavor?
"Correct. According to clinicaltrials.gov, this study is open for enrolment as of now. It was initially posted on March 28th 2023 and further amended on April 14th 2023. A total of 10 patients from a single site are being accepted into the trial."
Answered by AI
Can new participants still join this research endeavor?
"Clinicaltrials.gov currently demonstrates that this clinical trial is still in need of participants. It was originally posted on March 28th 2023 and most recently updated April 14th 2023."
Answered by AI
Has the 1.5 mg dosage of Psilocybin attained authorization from the Food and Drug Administration?
"With a score of 2, our team at Power has concluded that the 1.5mg dose of psilocybin is moderately safe based on existing Phase 2 evidence which supports safety but lacks proof for efficacy."
Answered by AI
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