Frequently Asked Questions
Why do we need clinical trials?
Clinical trials are important to understand more about whether a potential treatment may be better than current treatments. Clinical trials also help us learn more about the side effects of a potential treatment. Thousands of people all around the world take part in clinical trials every year. The medicines we buy at the pharmacy or at the doctors have all been tested in clinical trials before.
Is taking part in a clinical trial voluntary?
Yes, taking part in any clinical trial is completely voluntary. If you decide to stop taking part at any time, it will not affect your future medical care in any way.
What is informed consent?
Before you can join any clinical trial, you need to agree to join by giving your consent. You must understand everything about the clinical trial before you give your consent. This is called being ‘informed’. You should not feel any pressure to give your consent. Feel free to discuss the clinical trial with family and friends before you make your decision.
How will I receive the study treatment?
You will receive the study treatment from the trial team in the form of a capsule which you will take at the trial site.
Your dosing sessions will last about eight hours. If you need more time to be ready to leave the trial clinic safely, the session monitors and trial staff will stay with you longer. During the dosing sessions, you may experience changes in how you hear and see things, feel, and think for several hours. During the dosing session, both of your session monitors will stay with you to provide psychological support and take any necessary safety measures.
You will be accompanied home by a trusted adult (friend or family member) since you should not operate a vehicle or machinery within 24 hours of receiving your dose. Dosing sessions will be audio and video recorded for safety monitoring purposes.
How many visits would I have to make to the trial site?
You would need to make eight visits to your chosen trial site and eight remote visits by video call over a period of around four and a half months.
What will happen at psychological support sessions?
A licensed therapist with specialized training in EMBARK, a psychological support model for MDD, will work with participants during several psychological support sessions before and after the dosing sessions. They, along with a second session monitor, will also be in attendance with the participant during dosing sessions for both psychological support and safety purposes.
The pre-dose and post-dose sessions will last about 90 minutes each. At least one pre-dose session must be done in person and the others can be done in-person or remotely via an appropriate video call system.
The post-dose sessions will provide time for you to discuss your experience of the dosing session.
Are there any risks involved in joining the trial?
There are some risks linked to taking any medicine, and the investigational study treatment in the APPROACH clinical trial is no different. You may experience side effects or find that your symptoms do not improve or get worse. It is important that you tell your trial doctor if you are worried about anything or if anything about your health changes.
What happens after the clinical trial ends?
You will no longer receive the investigational study treatment after your part in the clinical trial has ended, even if you found it helpful. For any medical care you can contact your usual treating physician, as you did before the trial.
Participants will also have the option to join a long-term extension to the trial if they meet the requirements, where all participants will receive CYB003 with psychological support once they meet the requirements for dosing – there is no placebo group in this extension trial.
All of the data collected from each participant is anonymized and then analyzed by a team of scientists, who then produce a report with the findings for the professional bodies that oversee the development of investigational medicines. You cannot be identified in this report and your name will not appear in any results published.
Will I have to pay?
The investigational trial medication and all tests and procedures required by the trial are provided at no cost to you. The costs of other medications and treatments that you take or use independently of the trial are not covered by the trial Sponsor. You will be reimbursed for reasonable travel expenses, and meals, if applicable, for each trial visit.
What happens if I change my mind about taking part?
You are free to leave the trial at any time without giving a reason. It will not affect your regular medical care.
What happens to my personal information?
Information about your personal health will be kept private. If you decide to contact us, your details will be transferred to the trial team at the site you’ve chosen. Someone from the trial team will contact you to better understand if the trial is right for you. Your personal information will not be revealed to anyone outside of this trial team without your consent unless required by law or regulations of the local regulatory agency in your country.