Synergy Participant Information and Consent Form

Participant Information Sheet
Study title: A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group,
Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics including
Cognitive Function in Male and Female Participants in Remission from Depression
Study Number: SYND004
EudraCT No.: 2020-003748-10
Participant screening number: S|__|__|__| - |__|__|__|
Invitation paragraph
You are being invited to take part in a clinical research study sponsored by Syndesi Therapeutics
S.A. (the “Sponsor”), to evaluate an investigational medicinal product (study drug) for the
treatment of disorders of memory and learning associated with depression. The study drug is a
medicinal product that is still being studied to evaluate its efficacy, safety or mode of action, and
the one used in this trial is currently not on the market (available for you to buy) in any country.
Before you agree to take part in this study, you need to know how the study is organised and the
possible risks and benefits of taking part. This will allow you to make an informed decision
(known as informed consent) as to whether you want to take part. Part 1 of the information below
describes the purpose of the study and what will happen if you decide to take part. Part 2
provides more detail about the conduct of the study.
Part 1 of the information sheet
What is the purpose of the study?

The purpose of this study is to evaluate a study drug called SDI-118 to see whether it may be
helpful with disorders of memory and learning associated with depression. It is unlikely that there
will be any health benefits (given the short duration of treatment) of taking part in this study. So
far, over 88 healthy males and females have been administered this drug and to date, the
therapy was found to be well tolerated and has shown relatively few side effects. The study
Sponsor would like to explore whether SDI-118 may be useful in improving learning and memory
difficulties that some people may experience after depression in order to continue collecting data
on safety and tolerability.
This study is a ‘randomised’ study, which means that participants are put into one of 3 groups
and each group is given a different treatment. Two doses of study drug, (1.0 mg SDI-118 or 5.0
mg SDI-118) or placebo (dummy drug) will be evaluated in 3 equal sized groups. Each
participant will be put into one of the 3 groups by chance (randomly). You are more likely to
receive study drug (approximately 67% chance) than placebo. Neither you nor the study team will
know whether you are taking study drug or placebo (although if your doctor needs to find out,
they can do so). At the end of the study the results from the 3 groups will be compared.
Why have I been invited?
Protocol No. SYND004 Remitted PIS/ICF Final Clean version 3.0, 18January 2021
Investigator: Prof. Catherine Harmer and Dr Katharine Smith Page 1 of 16
You have been invited to take part as you have suffered at least 2 episodes of depression in the
past and have now recovered.
A total of 90 participants will take part in the study over the course of about 12 months, we will
compare information from the 3 groups of people to help us understand more about how the new
drug works. This study will take place at 3 centres across the UK.
Do I have to take part?
You do not have to take part in the study and your participation is voluntary and must remain free
from any influence. Even if you sign the informed consent you can stop your participation at any
time by informing the study doctor. Your decision to stop participating in the study will have no
impact on the quality of your care or on your relationship with the study doctor.
What will happen to me if I take part?
In summary, the study will include taking the study drug each morning for 16 to 18 days and
completing a number of questionnaires, memory and problem solving tasks. The study will
include 7 visits to the study site, and two of these will include a magnetic resonance imaging
(MRI) brain scan whilst completing some of the tasks.
A plan of the schedule of visits for the study is included below:
The visits involved in the study are outlined here:
The screening visit (Visit 1)

The purpose of the screening visit is to assess your suitability to take part in the study. Screening
is usually divided into two sections, with the first part being done by phone/video call. However,
you can choose to do the whole visit in person if you prefer. If done remotely, you will be asked to
provide electronic consent (e-ICF) before being asked any questions relevant to the study. In
order to provide this to you, you will need a computer, laptop, tablet or smart phone with internet
access. If you agree to proceed following a description of the purpose of the call you will asked to
enter your initials on the e-ICF, known as an e-signature. The researcher will then ask you
questions to assess your suitability to enter the study, for example about your previous episodes
of low mood and any treatment you received.
If you decide to take part, and the researcher feels that you are eligible for the study, you will be
invited to come to the study centre at the CRF Building at the Warneford Hospital site for the face
to face part of the screening assessment. If you do not meet the requirements it does not
necessarily mean that you are unhealthy, just that you are not suitable for this particular study.
The second part of the screening and subsequent visits will take place at research study centre
at the CRF Building at the Warneford Hospital site. This visit will take approximately 5 to 6 hours
and you will be offered a light snack during the visit. If you are invited to come to the study
centre, a researcher and a study doctor will go through the information sheet with you again and
answer any questions you may have about the study and your participation in it. This should take
about 30 minutes, but may take longer if needed. You are free to talk to others
(GP/family/friends) about the study if you wish. During this visit if you are still happy to take part
in the study you will be asked to sign the ‘informed consent form’ attached to this document. By
signing the informed consent form you are agreeing to take part and comply with all study
processes and procedures throughout the duration of the study.
The study doctor will confirm your suitability to take in the study, and will talk to you about any
current or past illnesses you might have had and will ask what medications you are taking. Some
medications may interfere with absorption or breakdown of the study drug and you may not be
allowed to participate, if you are taking them. You should not stop taking any prescribed
medication in order to take part in the study. We will measure your height, weight, body
temperature, blood pressure and pulse. A urine sample will be collected for safety tests, to test
for drugs of abuse and for pregnancy (for women of childbearing potential). You will also be
asked to complete an alcohol breath test. Blood samples will be taken for laboratory safety tests
which will include tests for HIV-Human Immunodeficiency Virus (the virus that causes AIDS),
hepatitis B or C infection. If a serious disease such as HIV or hepatitis infection is suspected,
you will be advised by the study doctor with respect to further information and medical care. This
is usually coordinated with your GP and/or family doctor. An electrocardiogram (ECG) will be
performed to check your heart and a study doctor will perform a physical examination, including a
neurological examination.
A member of study team will talk to you and ask you questions about your mood. You will be
asked to complete questionnaires about your behaviour, feelings, and memory, and asked to
complete some simple tasks about your memory. Taking part in the study involves taking images
of your brain using an MRI scan. If you and the study team feel it is necessary, you may have a
‘dummy’ MRI scan at this visit so you can understand what the scanning sessions will entail.
Before you to go in the scanner, you will be asked to read and sign an MRI Declaration Form.
This form lists the conditions you need to comply with, before undergoing the dummy MRI scan.
The scan will only be performed if you comply with what is required in the form and sign it.
When the results of the screening examination are available, the study doctor, in accordance with
the inclusion and exclusion criteria defined in the study protocol, will decide whether you can
participate in the study and will ask you to return to the research centre for the next study
procedures.
Visit 2 (within 7 to 28 days after visit 1)

This visit will take approximately 3 to 4 hours. We will measure your body temperature, blood
pressure and pulse again and will ask you about your health and any other medication taken
since the previous visit. A urine sample will be collected to test for drugs of abuse and pregnancy
(for women of childbearing potential). You will complete an alcohol breath test. If results of these
tests meet all the conditions required, you will be asked to sign the MRI Declaration Form and
you will then undergo your first brain scanning session, which will last in total approximately 75
minutes. The brain scan involves lying in an MRI scanner (a tube like machine) while viewing
images and words called visual stimuli which will be projected onto a screen. Whilst lying in the
scanner you will be able to view the screen and complete the requested tasks by making a
simple button press response using a button box. You will also be asked to stay still with no
particular thoughts in mind when your brain is being scanned in a rested state.
Visit 3 (1 day after Visit 2)

This visit needs to take place one day after Visit 2. This visit will take approximately 5 to 6 hours.
We will ask you about your health and any medication you have taken since the previous visit.
You will be asked to complete an alcohol breath test. A urine sample will be collected for safety
tests and to test for drugs of abuse. Blood samples will be taken for laboratory safety tests. An
electrocardiogram (ECG) will be performed to check your heart. We will also measure your blood
pressure, temperature and pulse. A study doctor will perform a physical examination, including a
neurological examination. You will then complete some problem-solving and memory tasks that
will be repeated at later visits, this will take approximately 50 minutes. A study doctor will talk to
you and ask you questions about your mood. You will complete some questionnaires about your
behaviour, feelings and memory, that will take approximately 30 minutes.
During this visit, an additional blood sample for pharmacokinetic assessment will be collected
before (together with the safety sample) and 2hrs after you are given your first study drug
capsule by the study team. Pharmacokinetic assessment is a measurement of how the study
drug is absorbed into and eliminated from your body. Before you leave the research facility, you
will be given the study drug bottle containing 9 capsules as the first capsule will have been given
to you by the study team. You will need to continue taking one (1) capsule with water every
morning at around the same time for the duration of the study except during visit 4, visit 5 and
visit 6, when you will bring your bottle with you and will wait for the study team to prompt you to
take your 1 capsule on site after some of the study procedures have taken place to allow blood
collection before and after study drug intake. During your participation in the study you will be
reminded to take your study medication daily by receiving an email or a text message per day
sent to your mobile phone. Your mobile number or your email address will be requested, to allow
us to send you the study drug intake reminder. You will only receive one text or email (depending
on your preferred method of communication). Your details will be entered by the study team in
the system sending the reminders, but your personal details will be encrypted and cannot be
accessed by anyone outside the site study team.
You will also be given a participant card, to carry at all times, including details of the study and
the study team.
Visit 4 (7 to 9 days after Visit 3)

This visit will take approximately 5 to 6 hours and contains the same procedures as Visit 3,
including blood samples for pharmacokinetic assessment before and after you take the study
medication and other tests including physical examination and electrocardiogram (ECG).
You will be asked to return the medication bottle to the site and the site staff will count the
remaining capsules in the bottle. The site will provide an additional bottle containing 10 capsules
for the next period.
Visit 5 (15 to 17 days after visit 3)

This visit is similar to visit 2. It will take approximately 4 to 5 hours. In addition to all assessments
completed at visit 2, we will ask if you have taken the study medication correctly. We will also
verify the study drug bottles contain the remaining study drug. The study team will ask you to
take the study drug in the facility. If all results are fine, you will then have your second and last
brain scan approximately two hours after medication intake.
Visit 6 (the day after visit 5)

This visit will take approximately 4 to 5 hours. We will repeat the pharmacokinetic blood sample
before and after you take the final dose of medication and also repeat the other safety tests,
including beath test, urine test, physical examination and electrocardiogram (ECG). You will
complete some problem-solving and memory tasks, you will be asked about your mood and
complete questionnaires about your behaviour, feelings and memory.
Visit 7 (12 to 16 days after visit 6)

This last study visit will take approximately 2 to 3 hours, and involves urine and blood samples,
ECG and physical examination, followed by an interview and questionnaires about your mood.
From Visit 1 to Visit 7, we will ask questions about your health and any adverse effects since the
last visit. If you are a woman of child bearing potential, you will have to take a pregnancy test at
each visit, Throughout the study you will be given a light snack during each of the visits.
Expenses and payments
If you decide to take part in this study all examinations and/or procedures necessary for the study
will be paid for by the sponsor. You will be paid an hourly rate of £20 for your time and
inconvenience in taking part in the study. We will also pay for any reasonable travel expenses to
and from the study appointments that you have upon production of valid receipts. This will mean
sharing your personal information with the finance department at University of Oxford. If you live
far away, the expense of overnight accommodation to allow you to attend the 2 subsequent visit
days will be refunded up to £100 per night. Please keep the receipts of these expenses and hand
them to the study team. Payment for your time in the study will be made after you have
completed visit 7 or after you are withdrawn from the study. However, payments for reasonable
travel or accommodation expenses (if necessary) will be made on an ongoing basis and as
incurred. Please keep all the receipts and hand them to the study team.
What will I have to do?

 You must be willing to attend each study visit.
 It is important that you tell us about any medication you are taking before and during the
study (including herbal medications, such as St John’s Wort) and/or any medication
prescribed by a doctor in a medical emergency. You should contact your study doctor
before starting any new medication during the study except paracetamol (maximum of 2 g
per day for 3 days in any 2 weeks). However, you should not delay taking any medication
prescribed by a doctor in a medical emergency, although the prescribing doctor should be
informed about the study medication you are taking.
 You must take your study medication as directed.
 You must carry your participant card at all times once you have been given it.
 You should consume your normal amount of caffeine throughout the study.
 If you feel sleepy as a result of taking the study medication you should not drive and
should take care when using machinery.
You must not do any of the following during the study:
 If you are a female, you must not be pregnant, planning a pregnancy or breastfeeding.
 If you are a male with a female partner of childbearing potential, your female partner must
not be breastfeeding nor must you or your partner be planning a pregnancy. Male
participants must agree that during the study and for 3 months after the last study visit not
to donate sperm.
 Take any illegal drugs.
 Eat foods containing poppy seeds for 48 hours before the Screening Visit and Visit 1 and
throughout the study.
 Drink, tea, coffee, colas, caffeinated drinks or energy drinks for the duration of the
assessment visits 2, 3, 5 and 6. You may drink your normal amount of tea/coffee on the
morning prior to the fMRI scanning assessments (Visits 2 and 5) and cognitive testing
assessments (Visits 3 and 6).
 Drink alcohol for 24 hours before each study visit.
 Drink more than 2 units of alcohol per day on other days. A unit of alcohol is defined as
250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.
 Consume grapefruit and grapefruit juice as well as other medication and herbal remedies
which may interfere with the way your body processes the study drug for 48 hours prior to
visit 2 and for the duration of the study
 Smoke more than 5 cigarettes per day, or use nicotine-containing products equivalent to
more than 5 cigarettes per day during the study. You must not smoke for 2 hours prior to
fMRI scanning assessment on Visits 2 and 5 or cognitive testing on Visits 3 and 6.
 Start any type of psychological treatment (talking therapy) during the study.
 Take part in any other research studies.
If you do not follow the study requirements, you may be withdrawn from the study.
Which parts of the study are outside normal clinical practice?
You would not normally complete some of the assessments, safety measurements, blood and
urine tests, MRI scanning or cognitive tasks in this study as part of standard care. However, the
safety laboratory tests, health checks, questionnaires, interviews, brain scans and many of the
tasks are used routinely in clinical practice. Some aspects of the study are experimental, such as
the study drug, some of the problem solving and memory tasks and some of the blood sampling.
For this study we will take no more than 150 ml (30 teaspoons) of your blood.
Cognitive tasks include tasks to assess verbal learning, reaction time, visual and working
memories, attention and cognitive speed of processing. Some of the tasks are performed on a
computer and others are completed on paper.
You will have Magnetic Resonance Imaging (MRI) brain scans as part of the study which is not
part of standard care. An MRI scanner generates a picture of the brain using magnetic fields and
radio frequency waves. MRI is non-invasive and does not involve any ionising radiation (x-rays).
However, because it uses a large magnet to work, MRI scans are not suitable for everybody. To
help determine if you are able to have an MRI scan the study team will ask you some pre-
screening questions. You must inform your study doctor if you have any of the following: if you
have a heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip,
hip replacement, or if you carry other pieces of metal in your body.
The MRI scanner is a large circular magnet with a tunnel down the middle. During the scan you
lie on your back inside the tunnel, and you will need to keep as still as possible. We will make
sure you are comfortable before the scan starts. As some of the scans are noisy, you will be
given earplugs to make this quieter for you. It is important that these are fitted correctly as they
are designed to protect your hearing. Participants will be introduced carefully to the scanner and
allowed to leave at any stage. Whilst in the scanner participants have easy access to a call
button they can use to stop the scan or speak to the radiographer or scan operator.
You will be asked to read and sign an MRI Declaration Form before the scan starts. This form
lists the conditions provided to you above for you to consider and confirm. You will perform the
scan only if you comply with what is required in the form and sign it. During the scan we will ask
you to complete some simple tasks as described in visit 2 above. You will also be asked to stay
still with no particular thoughts in mind when your brain is being scanned in a rested state.
The scan usually takes approximately 60 minutes. All brain scans are carried out by trained
radiographers.
What are the possible side effects, disadvantages and risks of taking part?
Study drug
All drugs may cause side effects. As with any other drug, you may also experience other
reactions that cannot be predicted. Sometimes people may have allergic reaction to drugs
(e.g. rash, shortness of breath, sudden drop in blood pressure, elevated heart rate and
sweating). In case of any health problem related to the study, you will need to inform the study
team immediately so that you can receive the right/adequate treatment. If any new information
comes to light during the study, which may affect your willingness to participate, this information
will be provided to you.
To date 3 clinical studies have been completed where the study drug was administered to 88
healthy male and female participants. In these studies, the most frequent (i.e. by at least
2 participants that received the study drug) reported side effects were dizziness, hypersomnia
(excessive sleeping time during the day), headache, fatigue, somnolence (sleepiness), asthenia
(lack of energy) and postural dizziness (dizziness upon standing).
All the reported side effects were mild to moderate in intensity. You may experience none, some
or all of these side effects. If you feel sleepy as a result of taking the study medication you should
not drive and should take care when using machinery.
There may be risks involved in taking this medication that have not yet been identified in
previously conducted studies, therefore, if you feel concerned about anything after taking the
study drug regardless of whether or not you think it has to do with the study you should contact
the study team straight away. If you would like to speak to someone before your next visit, please
refer to the contact details at the end of this information sheet.
It is possible that during the study we may discover that you have a medical condition that you
did not know about (e.g. high blood pressure). In this case, the study doctor will discuss with you
how best to seek help from your GP or other services.
The placebo treatment contains mannitol. Given the small quantities of mannitol, no side effects
are anticipated, although the same cautionary statements as above applies.
It is theoretically possible the questionnaires, interviews and tasks might arouse unpleasant
feelings or memories. The study doctor will be on hand to provide support and advice. Please
remember you can stop your participation in the study at any time.
Blood sampling
This may cause pain, bruising, light-headedness, fainting and extremely rarely infection.
However, to reduce these risks we will be using experienced phlebotomists (professional trained
to draw blood) to take these samples in a clinical setting.
MRI Scan
We will use MRI to produce images of your brain. These images will show us what your brain
looks like. They will also allow us to measure the activity in the various parts of your brain when
you are performing tasks and when you are at rest. We will use this to see what is happening in
your brain in various areas, such as those associated with thought, memory, and emotion, and if
there are any differences in the activities of these areas between your two MRI visits.
MRI is non-invasive and does not involve any ionizing radiation (x-rays). While there is no
evidence to suggest that MRI is harmful to unborn babies, as a precaution, the Department of
Health advises against scanning pregnant women unless there is a clinical benefit. If you think
you might be claustrophobic, please discuss this in advance with the researcher, or let the
radiographer or operator know before your scan.
In preparation for your scan and for your comfort and safety we may ask you to change into
pocket less and metal free “pyjama-style” top and trousers, which are available in a range of
sizes. You may keep your underwear and socks on but we would ask ladies to remove
underwired bras, if you have a suitable non-wired bra you may wear this instead. Please avoid
any fabrics that contain metallic threads or have been silver impregnated (often marketed as anti-
microbial/bacterial or anti-odour/stink). Metal jewellery including body piercing must also be
removed. Eye shadow and mascara must also be avoided, since some types contain materials
that can interact with the magnetic field. If you wish to wear eye makeup to your scan we can
provide makeup removal wipes but you are advised to bring your own makeup to reapply.
Lockers are provided to secure your personal belongings and clothing.
Participants will be introduced carefully to the scanner and allowed to leave at any stage. Whilst
in the scanner participants have easy access to a call button should they wish to stop the scan or
speak with the radiographer or operator.
It is important to note that we do not carry out scans for diagnostic purposes, only for research.
Our scans are not routinely looked at by a doctor and are therefore not a substitute for a doctor’s
appointment. Occasionally, however, a possible abnormality may be detected. In this case, we
would have the scan checked by a doctor. If the doctor felt that the abnormality was medically
important, you would be contacted directly and recommended to have a hospital (NHS)
diagnostic scan arranged. You would not be informed unless the doctor considers the finding
has clear implications for your current or future health. All information about you is kept strictly
confidential.
Contraception, pregnancy and breastfeeding
The effects of the study drug on an unborn child or infant are unknown, therefore, women of child
bearing potential and men who have a female partner of childbearing potential, must use a highly
effective birth control method when accepting enrolment into this study. As a female participating
in this study you should not be pregnant, wish to become pregnant or be breast-feeding.
Highly effective birth control methods include the use of a physical barrier (condom) plus a
secondary form of contraception for the female (birth control pills, intra-uterine device or IUD,
vaginal ring). Please discuss your options with the study team as they can explain more about
contraceptive requirements.
Abstinence is acceptable only as true abstinence: when this is in line with your preferred and
usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception.
During the study, you and/or your partner must use a highly effective contraceptive method.
There are some exceptions to this (for example if you have gone through the menopause, had a
hysterectomy or other relevant surgical procedures) and your study doctor will assess and
discuss this with you at the screening visit.
It is also important that if you are male, your partner does not become pregnant and you do not
donate sperm for the duration of the study, and up to 3 months after the last administration of the
study drug. In addition, you must inform your partner of your participation in this study and of the
potential risk to an unborn child.
If you are a woman of childbearing potential, you will have urine pregnancy tests performed at
visits 1, 2, 5 and 7 (final study visit). This test must be confirmed negative before you can
continue the visit and receive study drug. If your pregnancy test is positive or you become
pregnant during the study, you will be withdrawn from study treatment.
In any case, if you (for women) or your partner (for men) become pregnant during the study, you
must notify the study doctor immediately
What are the possible benefits of taking part?

There are no direct benefits to you taking part in this study. However, the information we get from
you will help us to understand more about the safety and tolerability of the study drug and how
the study drug affects the performance of learning and memory tasks. You will not be able to
continue taking the study medication after the end of the study as it is not yet licensed or
available as a treatment.
This completes Part 1. If you are still interested in participating in the study please read the
additional information in Part 2 before making your final decision.
Part 2 of the information sheet

What if relevant new information becomes available?
Your study doctor will tell you if any new information on the treatment becomes available which
may affect your decision to continue in the study. An updated information sheet will be given to
you by the study team and discussed with you. If you decide to continue in the study, you will be
asked to sign an updated Consent Form. Should you wish to learn more about the study results
you can contact your study doctor who will be able to provide you with a summary of the study
results once this becomes available.
What will happen if I don’t want to carry on with the study?

You are free to leave/withdraw from the study at any time. If you decide to withdraw from the
study, you will be invited by the study doctor to attend some follow up visits in order that the
study doctor can assess your state of health. To guarantee the validity of the research, the data
encoded up to the point at which you withdraw will be retained. Any stored samples that have not
been analysed will be destroyed if you wish.
Withdrawal from the study
Your participation is voluntary, and you are entitled to withdraw from the study for any reason,
without having to justify your decision. Nevertheless, it may be useful for the study doctor and for
the sponsor of the study to know if you are withdrawing because the constraints of the treatment
are too great (too many uncomfortable side effects, for example).
The study doctor may decide to withdraw you from the study for any of the following reason:
 If you develop an illness that the study doctor feels would make you unsuitable for the
study.
 If you take a medicine or receive a treatment that is not allowed during the study.
  If you are a woman and become pregnant.

 If you have used drugs and test positive for this.
 If you test positive for alcohol.
 If you are unable to be scanned.
 If you do not take your study medication as you have been asked to do.
 If you do not turn up to your visits.
Finally, the competent national or international authorities, the ethics committee that initially
approved the study or the sponsor may stop the study because the information gathered shows
that the investigational treatment causes more side effects or more serious side effects than
anticipated, or for any other reason, such as, the decision to stop research and development of
the investigational medicinal product.
At the point of withdrawal or any form of withdrawal as per the above or when the scheduled
participation period has ended, your study doctor will assess your state of health and where
appropriate and/or necessary he or she will refer you to your own GP.
What if there is a problem?

Complaints
If you have a concern about any aspect of this study, you should contact the study team and we
will do our best to answer your questions. If you remain unhappy and wish to complain formally,
please contact Professor Catherine Harmer, on the telephone number +44 (0)1865 618326.
If you need further information, but also if you have problems or concerns, you can contact the
study doctor Dr Katharine Smith at 01865 902135 or a member of her study team Miss Sorcha
Hamilton, on the following telephone number +44 (0)1865 618315 or by emailing
synergy@psych.ox.ac.uk
In case of emergency, you can contact the on-call medic team on the switchboard telephone
number 01865 901000.
Outside consulting hours, contact the A&E department of your hospital, indicating that you are
taking part in a clinical study. Your records will contain information about your participation in this
study which the on call doctor will be able to access by contacting a member of the study team.
If you have any questions relating to your rights as a participant in a clinical study, you can
contact the University of Oxford Data Protection Officer, James Bristow on this email address
data.protection@admin.ox.ac.uk. If necessary, he can put you in contact with the ethics
committee.
Harm
Any participation in a clinical study involves a risk, however small it is. Even if there is no fault,
the sponsor accepts responsibility for damage caused to the participant (or in the event of death,
his/her dependants) and directly or indirectly linked to his/her participation in the study. The
sponsor has taken out insurance for this responsibility.
You are therefore asked to report any new health problem to the study doctor. He/she will be
able to provide you with additional information concerning possible treatments.
If the study doctor believes that a link with the study is possible (the insurance does not cover the
natural progression of your disease or the known side effects of your normal treatment), he/she
will inform the study sponsor, which will initiate the declaration procedure to the insurance
company. The latter will appoint an expert - if it considers it necessary - to assess whether there
is a link between your new health problems and the study.
In the event of disagreement either with the study doctor or with the expert appointed by the
insurance company and whenever you feel it is appropriate, you or - in case of death - your
dependants may bring proceedings against the insurer directly in the UK (Chubb, policy
UKLSCD22747.
If you are physically injured as a direct result of receiving the study drug or device or any properly
performed procedure, and suitable care cannot be provided by the NHS, reasonable and
appropriate medical treatment will be provided to you, using an appropriate non-NHS medical
service, free of charge by the study sponsor in accordance with the most recent Association of
British Pharmaceutical Industry (ABPI) guidelines, a copy of which is available on request from
your study doctor or located here https://www.abpi.org.uk/publications/ct-compensation/.
Will my taking part in this study be kept confidential?
By signing this form, you understand that the study team will be collecting and using personal
data about you for the study . You are entitled to ask the study doctor what data are being
collected about you and their use in connection with the study. These data concern your current
clinical situation, some background information, the results of examinations carried out within the
context of your health in accordance with the current standards and any results of examinations
required by the protocol. You have the right to inspect and correct these data as
appropriate/necessary.
Your name and contact details will be kept separately from your other study data and will be
linked only by a code number that is specific to you. The researchers hold a code key, which is
needed to connect your study data to you.
Study data will be collected via paper and/or computer. All paper data will be stored securely in
locked cupboards and any data held on a computer will be password protected. All study data
leaving the site will be identified only by the code number generated in the study and date of
birth. We will keep your study data for 15 years after the completion of this trial.
If you join the study, any study data held by the research site may be looked at by authorised
persons from the study site, the study sponsor and their delegates. The research site will use
study data to help with the conduct of the study. The sponsor company and their delegates may
use study data to conduct and report the results from the study, to support applications for
approval of the study medication and for research related to the development of pharmaceutical
products, diagnostics or medical aids, they may send your results to other countries where laws
about keeping information are less strict than in the UK and Europe. The data collected on this
occasion are confidential and your anonymity is guaranteed during publication of the results.
Study data may also be looked at by the authorities who control medicines and representatives of
the University and NHS trust to check that the study is being carried out correctly. Your data
collected in this study may be used in future research. However, your data will always remain
anonymous that is your name and personal details will never be shared externally. You may
choose not to give your consent to your data being in any future research in which case it will be
only used in the context of this study.
Your consent to take part in this study also implies your consent to the use of your encoded
medical data for the purposes described in this information sheet and to their transmission to the
people and authorities mentioned above.
If you withdraw your consent to take part in the study, to guarantee the validity of the research,
the data encoded up to the point at which you withdraw will be retained. No new data will be sent
to the sponsor.
If you take part, we will ask you for your consent to contact and inform your GP about your
participation. When we contact your GP they will be asked to provide specific information from
your medical notes relating to the study requirements. With your permission, we can also tell
them of any important medical conditions found during the study, including depression, so that
they can help you.
Information will be used by people conducting the research under your research doctor’s
responsibility as well as people working on behalf of the company sponsoring the research and
any affiliates, which could include service providers or subcontractors.
You must not take part in too many studies because it may not be safe for you. To help research
units like ours, the Health Research Authority keep a database of healthy volunteers when they
take part in studies, this is called TOPS (The Over-volunteering Protection System). The type of
information about you which will be entered into the TOPS database is below:
 National Insurance (NI) number (if you are a UK citizen) and date of your last dose
of study medicine
or
 Passport number and country of origin (if you are a foreign national and have a
non-UK passport) and date of your last dose of study medicine.
Syndesi Therapeutics, a pharmaceutical company and the Sponsor of this study, is the Data
Controller, has a legitimate interest to process your data and will be responsible for the use,
security and management of all data generated in the study.
Data Controller contact details: Syndesi Therapeutics is located at Chemin du Cyclotron 6, 1348
Louvain-la-Neuve, Belgium.
Everyone who has access to study data has a duty of confidentiality to you as a research
participant and is responsible for handling study data in accordance with GDPR. (General Data
Protection Regulation) and applicable laws. In the UK we follow GDPR rules and have a law
called the Data Protection Act. All clinical studies using research participant data must follow UK
laws and rules. This means that your information is:
 used fairly, lawfully and transparently
 used for specified, explicit purposes
 used in a way that is adequate, relevant and limited to only what is necessary
 accurate and, where necessary, kept up to date
 kept for no longer than is necessary
 handled in a way that ensures appropriate security, including protection against unlawful
or unauthorised processing, access, loss, destruction, or damage
Your rights regarding the use of your information: a right of access, correction, deletion and
restriction of the processing, the right to object to the use of your information and the right to
move your information (data portability). However, researchers do need to manage your records
in specific ways for the research to be reliable and accurate. This means that they will not be able
to let you see or change the data they hold about you. Research could go wrong if data is
removed or changed.
Your initial point of contact for the processing of your personal data and to exercise your rights
remains your study doctor. If you require further clarification about the processing of your data,
you may contact the Data Protection Officer of the Sponsor on +44 56 0375 0073, by email to
gb.syndesi004@mydata-trust.info or by post Boulevard Initialis 7/3, 7000 Mons, Belgium.
You also have the right to complain about how your personal data is handled to the UK’s data
protection (ICO) authority that is responsible for enforcing data protection law. The ICO can be
contacted at: Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.
In order to exercise the above rights, please contact James Bristow, the University Data
Protection Officer, at any time by email at data.protection@admin.ox.ac.uk or in writing to the
address University of Oxford, University Offices, Wellington Square, Oxford, OX1 2JD.
What will happen to any samples I give?
Blood and urine samples for routine analysis will be labelled with your code number and other
study information and sent to a UK laboratory for analysis. They may be retained for up to three
months to allow re-testing and will then be destroyed. Urine samples for drug screening and
pregnancy tests will be destroyed on the day of the visit.
A blood sample will be taken for study drug analysis to look at levels of study drug in your body.
This will be sent to a laboratory in Europe for analysis and will be stored for no longer than 15
years after the end of the study by the Sponsor company’s laboratory.
If you withdraw your consent to take part in the study, you may contact the study doctor and have
any samples that have not yet been used destroyed. The results obtained from your samples
before you withdraw your consent remain the property of the study sponsor.
What will happen to the results of the research study?
The data and results from this study may be published in medical journals or used in scientific
reports and may be communicated to the regulatory authorities. If you wish to know about the
study outcome, you can check a publicly available website www.clinicaltrials.gov. It is not
possible to say at this point when this will be. You will not be identified by name in any such
publications.
What if we find something unexpected?
If any of the tests completed as part of this study show that there is an illness or problem that can
be managed by you or your doctor to improve your health, then your study team will let you know
and work with you on how best to follow up these findings. With your consent, this may involve
discussion with your GP or another appropriate doctor. Such findings we would refer to as being
‘clinically relevant’. You will not routinely be informed of research study test results.
It is important to note that we do not carry out scans for diagnostic purposes, only for research.
Our scans are not routinely looked at by a doctor and are, therefore, not a substitute for a
doctor’s appointment. Occasionally, however, a possible abnormality may be detected. In this
case, we would have the scan checked by a doctor. If the doctor felt that the abnormality was
medically important, you would be contacted directly and recommended to have a hospital (NHS)
diagnostic scan arranged. You would not be informed unless the doctor considers the finding has
clear implications for your current or future health. All information about you is kept strictly
confidential.
Who is organising and funding the research?
A pharmaceutical company called Syndesi Therapeutics Chemin du Cyclotron 6, 1348 Louvain-
la-Neuve, Belgium is funding this research and is called the ‘Sponsor’. They are also the
controller of the data. Administrative, data management and organisational support for the study
will be provided by P1vital Limited. P1vital is a company specialising in experimental medicine
studies for psychiatry and obesity.
Who has reviewed the study?
This study has been reviewed and approved by the Berkshire B Research Ethics Committee and
by the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA).
It is the task of the Ethics Committees to protect people who take part in a clinical trial. They
make sure that your rights as a patient and as a participant in a clinical study are respected, that
based on current knowledge, the balance between risks and benefits remains favourable to the
participants, that the study is scientifically relevant and ethical.
You should not under any circumstances take the favourable opinion of the Ethics Committee as
an incentive to take part in this study.
Further information and contact details
If you would like general information about research, this can be found on many websites
including www.crncc.nihr.ac.uk/ppi/ppi_involve . If you would like more information about this
study and whether you should participate, please contact one of our study team members on the
number given below. You could also ask family, friends and your GP about whether to take part.
Throughout the study you can contact us to answer questions. During the day you will have
immediate access to advice. You will be given the number for our out of office hours (for study
related queries which cannot wait until the next working day) when you come for your first
appointment.
You will be given a copy of this information sheet and a signed consent form to keep. The study
doctor will also sign this form to confirm that he/she has provided you with the necessary
information about the study.
Thank you for taking the time to read this.
Contact number for Professor Catherine Harmer and her study team:
+44 (0)1865 618326
Informed Consent Form
Study title: A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group,
Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics including
Cognitive Function in Male and Female Participants in Remission from Depression
Centre Number:
IRAS Number:
Study Number: SYND004
EudraCT No.: 2020-003748-10
Participant Identification Number: ............................................................

PLEASE INITIAL BOX
I declare that I have been informed of the nature of the study, its purpose, its duration, any risks and
benefits and what is expected of me. 
I confirm that I have read and understand the information sheet version 3.0 dated 18 January 2021 for the
above study. I have been given time and the opportunity to ask questions and have had these answered
satisfactorily.

I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any
reason, without my medical care or legal rights being affected. 
I understand that relevant sections of my medical notes and data collected during the study, may be looked
at by individuals from the Syndesi and their authorised delegates, including P1vital, from regulatory
authorities or from the University and NHS trust, where it is relevant to my taking part in this research. I give 
permission for these individuals to have access to my medical notes and study data.
I understand that my rights to compensation may be affected if I fail to disclose to the researchers any
relevant information which may affect my participation in this study, or if I fail to follow the requirements of
the study.

I agree for you to enter into a database either my National Insurance number (if I am a UK citizen) or
my passport number and country of origin (if I am a foreign national with a non-UK passport), and the
date of which I receive my last dose of study medicine (or the fact that I never received a dose).

I understand that my personal data, including data relating to my physical or mental health or condition, and
race or ethnic origin, may be used as described in the information sheet, including transfer to countries
outside of the UK and the European Union.

I agree to my GP being informed of my participation in this study. I agree to my GP providing specific
information from my medical notes relating to the study requirements. 
I agree to give blood samples in the study. I know that blood sample will be taken to analyse study drug
level in my body and will be kept for up to fifteen year after the end of the study. I understand that I will not
receive the results of these analyses.

I understand that MRI performed in this study is a research scan that is not useful for medical diagnosis,
and that scans are not routinely looked at by a doctor. If a concern is raised about a possible abnormality
on my scan, I will only be informed if a doctor thinks it is medically important such that the finding has clear 
implications for my current or future health.
I understand that the information collected about me may be used to support other research in the future,
and may be shared anonymously with other researchers (please circle one of the options below as
appropriate)
Yes
No
I agree for the study team to keep my contact details and to be contacted for future research opportunities
(please circle one of the options below as appropriate)
Yes
No
Informed Consent Form
I understand that although safety measures are in place to reduce my risk of possible Covid-19 infection
during this study, I enter the study at my own risk. I agree I have told study team if I am a vulnerable or
extremely clinically vulnerable person. (please circle one of the options below as appropriate)
Yes
No
I declare that neither myself or any of my household has been confirmed Covid-19 positive or had Covid-19
symptoms in the last 14 days (temperature, new continuous cough and/or change in taste or smell). (please
circle one of the options below as appropriate)
Yes
No
I declare that I currently feel well and do not have Covid-19 symptoms (temperature, new continuous cough
and/or change in taste or smell) and that if I, or a household member,develop Covid-19 symptoms during
the course of this study I will immediately notify the study team. (please circle one of the options below as
appropriate). .
Yes
No
I have received and read a copy of the Participant Information Sheet/ informed consent form and I agree to 
participate in the study.
Signature: Date: Time:

Full name of Participant:
Signature: Date: Time:
Full name of investigator taking consent:
When completed: 1 for participant; 1 for researcher site file.

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Participant Information Sheet

Study Number: SYND004

EudraCT No.: 2020-003748-10

Participant screening number: S|__|__|__| - |__|__|__|

Part 1 of the information sheet

What is the purpose of the study?

Why have I been invited?

A plan of the schedule of visits for the study is included below:

The visits involved in the study are outlined here:

The screening visit (Visit 1)

Visit 2 (within 7 to 28 days after visit 1)

Visit 3 (1 day after Visit 2)

Visit 4 (7 to 9 days after Visit 3)

Visit 5 (15 to 17 days after visit 3)

Visit 6 (the day after visit 5)

Visit 7 (12 to 16 days after visit 6)

What will I have to do?

What are the possible benefits of taking part?

Part 2 of the information sheet

What will happen if I don’t want to carry on with the study?

  If you are a woman and become pregnant.

What if there is a problem?

Thank you for taking the time to read this.

Study Number: SYND004

EudraCT No.: 2020-003748-10

Participant Identification Number: ............................................................

Signature: Date: Time:

Signature: Date: Time:

Full name of investigator taking consent:

When completed: 1 for participant; 1 for researcher site file.

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Participant screening number: S|||| - ||||