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Psilocybin Effect on Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients

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We are looking to improve the quality of life for people with autism. It’s the fastest growing developmental disability in the world, increasing at a rate of 10-17% each year, and many struggle to find effective treatment options.  

Fragile X Syndrome (FXS) is a genetic neurological disorder caused by a mutation on the X chromosome in the Fragile X messenger ribonucleoprotein 1 (FMR1) gene, typically due to the expansion of the CGG repeat.  Approximately 1 in 7000 males and 1 in 11,000 females are affected with FXS. Fragile X syndrome is associated with a range of developmental problems, such as learning disabilities, cognitive impairments, mood instability, compulsive disorders and sensory hypersensitivity. Many children also exhibit autism spectrum symptoms such as poor eye contact, shyness and hand-flapping. This diverse range of symptoms makes FXS difficult to treat. A novel therapy to help treat some of these symptoms with oral microdose psilocybin therapy is under investigation.  

Psilocybin is a naturally-occurring psychedelic that is produced by more than 200 species of fungi (mushrooms). Psilocybin is a serotonin agonist and activates the serotonin receptor 5-HT2A. We know that serotonin levels are much lower in ASD and FXS children and they miss key peak levels needed for normal brain development. 

We believe that serotonergic insufficiency during childhood may have a compounding effect on brain patterning in ASD and FXS, manifesting as behavioural and emotional symptoms. Psilocybin is expected to mimic serotonergic signaling when innate serotonin synthesis is low, as is common in developmental delay. 

Psilocybin has low risk for physical or psychological dependence and is not generally considered to be toxic even at high doses. 

 Psilocybin at microdose levels is proposed to be a first-in-class treatment for FXS. A microdose is approximately one-tenth of a full dose. 

 We believe that repetitive microdosing could provide greater benefits, as compared to full-dose interventions, with less risk of adverse reactions and without the hallucinogenic effects experienced with higher doses. 

Micro-dosing of psilocybin has been shown to improve depression, anxiety and addictions offering a more holistic approach to therapy. Psilocybin may help improve brain plasticity and reduce anxiety and behavioural rigidity. (Do you have articles showing the effect of microdosing in depression, anxiety, and addictions?) 


 Other treatments for FXS involve pharmaceutical and behavioural interventions. Psilocybin provides a potential alternative that may be able to improve cognition, communication, mood, and behaviour problems as well as other possible benefits.  


This study will be an open-label, single arm 28-day study with the intent to study the effects on behavioural and cognitive impairments. Visits to the clinic will occur weekly and all initial doses will be started at the KGK Science clinic under medical supervision to watch for adverse effects. 


Paid compensation of up to $ 750 for each qualified participant upon completion of this study. 


Eligible participants will need to be: 

  • Adults diagnosed with Fragile X Syndrome 
  • Willing to take microdoses of Psilocybin. 
  • Ability to swallow tablets/Capsules. 
  • Relatively Healthy Individual 
  • Interested in helping to advance Fragile X Syndrome treatments 



If interested in participating in this study, sign up now to be added to our waiting list. 


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Why participate in a KGK clinical study?

  • Discover new natural health and wellness products

  • Receive compensation for your participation

  • Contribute to advancing global health research 

the process

  • Pre-Screening Online

    Take a 2-minute survey to assess your eligibility.

  • Telephone Screening

    Tell us about yourself to see if you may qualify.

  • Screening Visit

    A few simple tests to fully qualify as a study participant.

  • Participate

    One or more clinic visits over the course of the study.

  • Receive Compensation

    KGK thanks you for your participation with monetary compensation.  

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Clinical Trials FAQ

What is a clinical trial?

Clinical trials on natural products are research studies in which people help doctors and researchers test out claims that are made on health and wellness products. Having scientific evidence to back up the claims on natural products helps give consumers like you confidence that the products you are buying are safe and effective.

Who conducts a clinical trial?

At KGK Science, our studies are overseen by medical doctors and a proficient team of nutritionists and clinical coordinators who will guide you through each step of your participant experience.

Who is eligible to participate in a clinical trial?

Each study has its own guidelines called “eligibility criteria”. To ensure the strongest results, researchers want study participants to be alike in key ways. Examples of eligibility criteria for a trial might be age, gender, weight/height ratio and/or your previous medical history.

Will it cost me any money to join a clinical trial?

No, there are no out of pocket expenses for you to join a clinical trial other than your travel expenses to and from the clinic site. KGK Science provides you with all the necessary requirements to participate, including parking fees AND you are compensated for your time.

How long do your studies last?

Some studies are only one full day, and others may run for a few weeks or months. The schedule of visits and duration is discussed with you prior to you making a commitment to join the study.

Is my participation confidential?

All records relating to your identity and study participation are confidential as per the Personal Information Protection Act (PIPA), the Health and Information Protection Act (HIPA) and the Electronic Documents Act.

How do I sign up?

If you are interested in a study we are recruiting for, you can either contact us via phone, email, or online contact form and one of our recruitment team members will respond with more information or you can fill out a pre-screen survey and find out right away if you could be eligible.

How do I know if I qualify?

After you contact us or fill out your pre-screen survey, we will arrange a time to go through a telephone screening with you, asking you more specific qualifying questions and informing you of the details of the study. If you are eligible, you may be asked to come to our clinic for a personal screening visit. Once we complete the screening visit, if you qualify you will be contacted to enroll in the study.

What are the other requirements?

Some studies require you to keep an electronic diary of your food intake or certain activities throughout the day. KGK provides access to a free web app to record your entries and you are paid for this additional time off site.

Are clinical trials safe?

Researchers, doctors, and other health professionals conduct research studies according to strict rules set by the Food and Drug Administration (FDA), Health Canada and other regulatory agencies. These rules are to protect clinical trial participants and to make sure they are treated as conscientiously as possible. Research studies are also overseen by medical ethics groups to ensure that study participants are treated correctly.

Can I leave a research study once it has begun?

Yes. You are free to leave the trial at any time. If you do decide to leave, you should let the research team know and tell them why you are leaving the study. Early termination measures will be done to ensure your safe exit from the study.

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We test many types of health and wellness products from dietary supplements, functional foods & beverages to cannabis, beauty topicals and personal care products. You will be provided information in writing about the product you will be taking to review during the Informed Consent process. If you have any allergies at all, please let us know when you call in.

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