PARTICIPATE ONLINE
REQUEST A PAPER COPY
ABOUT THE STUDY
The aim of the ClozaGene Study is to try to find environmental and genetic factors that may influence how well Clozapine works.
Clozapine can also be called Clopine or Clozaril. Clozapine can be used to treat Schizophrenia but may be prescribed for other reasons.
We are also trying to find out why some people taking Clozapine experience side-effects. This research is important because Clozapine does not work for all people and can have unpleasant side-effects.
We are also interested in understanding what the symptoms or conditions are for which Clozapine is prescribed, including Schizophrenia. We would also like to find out if the genetic factors that influence these symptoms or conditions also influence a person’s response to Clozapine.
This study is open to adults who have been treated with Clozapine, Clopine or Clozaril.
WHO IS RUNNING THE SURVEY?
The ClozaGene Study is being conducted by researchers from the Mental Health Research Program at the QIMR Berghofer Medical Research Institute, a not-for-profit research institute located in Brisbane, Queensland. QIMR Berghofer is a world-leading medical research institute, renowned for our efforts in both discovery and translational (real patient setting) research.
This research project has been approved by the Human Research Ethics Committee of the QIMR Berghofer Medical Research Institute (QIMRB-HREC).
WHAT DIFFERENCE CAN I MAKE BY PARTICIPATING?
Participating in this study can make important contributions to improving outcomes for individuals who need to use Clozapine.
There is no direct clinical benefit to participants. This is not a treatment-based study or clinical trial.
WHAT DOES THE SURVEY INVOLVE?
If you choose to participate, we will ask you to provide your consent and fill in a survey. This can be done online or you can request a paper version that we will send to you.
The survey asks you about your experiences taking Clozapine, including any side effects you might have experienced. The survey also asks how your mental health is at the moment and about how your employment and relationships might have been impacted by your mental health.
We will also ask permission to access your pathology records relating to tests you may have had because you were taking Clozapine, such as your Clozapine levels or blood cell counts.
We may also ask you to supply us with a sample of saliva, which we will use to extract DNA to look for genetic factors that influence these traits.
HOW LONG DOES IT TAKE?
The survey may take around 20 minutes.
We may contact you after the survey is completed to discuss donating a saliva sample. If you agree to give a saliva sample, we will send you a sample collection kit.
Saliva samples can be collected in the privacy of your own home at a time that suits you. Providing a sample takes about 5-10 minutes. The saliva sample is sent back to us through the post using a pre-paid envelope.
I AM READY TO PARTICIPATE – WHAT NEXT?
If you would like to participate online, click here. If you would like to get a paper copy, instead please click here to tell us where to send it. We will include a prepaid envelope so you can return it to us for free.
Once you have completed the survey, we will send you a saliva collection kit. You provide a saliva sample yourself in your own home. Then you post the kit back to us using the pre-paid envelope that we provided.
CONTACT US
You may find that the answers to your questions are listed in our Frequently Asked Questions Section below.
If you require any further general queries about the Clozagene Study, please see our contact details below:
Email: clozagene@qimrberghofer.edu.au
Call: 1800 257 179
Write to: Locked Bag 2000, Royal Brisbane Hospital, Herston, QLD, 4029, AUSTRALIA
FREQUENTLY ASKED QUESTIONS
WHO CAN PARTICIPATE?
Researchers are seeking adults who live in Australia who have taken the medication Clozapine.
To show our appreciation for the time and effort given by participants in the ClozaGene Study, each participant will receive an e-gift card to the value of $30 at the end of their participation in the study.
There is no direct clinical benefit to participants. This is not a treatment-based study or clinical trial.
WHAT IS THE PROCESS OF PARTICIPATING?
- Reading and understanding the study information sheet;
- Providing consent for participating in the study;
- Providing consent for researchers to access your pathology records [optional];
- Providing contact information;
- Completing the survey; and
- Donating a saliva sample
After completing the survey, you will be asked to donate a saliva sample. We will extract DNA from the saliva to allow us to investigate genetic factors that influence the symptoms or conditions for which Clozapine is prescribed, as well as side effects experienced from taking Clozapine.
Researchers will send a saliva collection kit together with a pre-paid return envelope to selected participants.
CONFIDENTIALITY AND GENETIC DATA STORAGE
Study participation is strictly confidential. All patient information provided will be maintained in accordance with the Commonwealth Privacy Act (1988) and National Health and Medical Research Council (NHMRC) Guidelines.
Your personal details, questionnaire data and genetic information will all be stored in separate, firewalled password protected databases, and the only link between your personal details and your other data is your participant identification number.
The databases and samples are stored separately – the data collection team can only access your personal and survey information, analysts can only access your survey information and genetic data, and laboratory staff can only access your biological sample and DNA. This separation protects the confidentiality of participants.
When results are published, no individual results are included.
Participant DNA will be stored at QIMR Berghofer Medical Research Institute.
This research is not designed to provide any clinical results to participants. The study does not undertake individual analysis of each sample provided, but rather analyses all samples together.
If you have a personal interest in obtaining a genetic test, we suggest you consider contacting a genetic testing entity which can provide such testing.
We want to provide as much feedback as possible to participants about the study. In the consent form, we will ask you if you would like to receive study updates. If you agree, we will send updates via email during the study.
A copy of the Participant Information Sheet can be found here.
In this study, we are not conducting clinical genetic testing. We are also not providing participants any personal or family information from the research. Because of this, under the current Australian guidelines you do not need to disclose to Insurers that you participated in this study. For further information, refer to this summary article discussing insurance and genetic research, as well as Section 10.3 of the Financial Services Council policy on genetic testing and research (fsc.org.au).
PROVIDING A SALIVA SAMPLE
Please wait half an hour after smoking, drinking, eating, chewing gum or brushing your teeth before you provide your saliva sample.
If you are having trouble producing a sample, please visualise squeezing a half-lemon.
Please note that any volume is useful, even with bubbles.
If you are still unable to produce a sample, take a teaspoon of water, vigorously swish it around in your mouth and add that to the tube.
If you find the saliva collection kit is not suitable for you to use please let us know as there are other sample collection options available that we can provide. Please call or email us using the contact details below if this is an issue.
Even if your saliva sample is discoloured in the tube (e.g., lipstick or food scraps or blood), there is still plenty of your DNA in the tube for us to extract and use. Please return it to us and if we need you to provide another sample we will be in contact.
Please find instructions on how to provide a saliva sample into the tube here
Alternatively, please watch the instructional video here: