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.
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).
Participation
This study is open to adults who have been treated with Clozapine, Clopine or Clozaril.
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.
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.
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.
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.
Participate in the Study
FAQ
Any information that can identify participants will remain confidential. All of the data, including MBS and PBS information, will be coded with a unique Participant ID number and stored separately from personal information, such as name and address. It will be stored on a secure server at QIMR Berghofer Medical Research Institute and will only be accessible to approved study personnel. No personal information will be used outside this research study or in any reports from the study.
All the information we collect will be kept for at least 15 years after the end of the study. After this all identifying information will be permanently deleted from the computer system and any hard copies will be destroyed. This will ‘de-identify’ the data and make it impossible for anyone to link the information back to participants. Data will be destroyed securely by the IT Department at QIMR Berghofer according to their standard protocols. In addition to this research project, we may also use participant information for future projects related to cancer. Any such projects will have to be approved by the relevant scientific and ethics committees. Participant information will not be disclosed to anyone else without permission, except as required by law.
Health records and any information obtained during the research project are subject to inspection (for the purpose of verifying the data) by the relevant authorities. This includes authorised representatives of the Sponsor, Professor Penelope Webb, the participant’s Institution, Princess Alexandra Hospital, or as required by law. By signing the Consent Form, participants authorized the release of, or access to, this confidential information for the relevant study personnel and regulatory authorities as noted above.
Information about participation in this research project will be recorded in the participant’s health records.
The results of this research project may be published and/or presented in a variety of forums but information will only be provided in such a way that participants cannot be identified, without permission. For example, we will only report results for groups of people and not for individuals.
In accordance with relevant Australian and Queensland privacy and other relevant laws, participants have the right to request access to your information collected by the research team. Participants also have the right to request that any information with which they disagree be corrected. Participants are welcome to contact the study project team members named above if they would like to access their information.
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.
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.
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.
Can I access my genetic data? 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.
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).
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.
Contact
You may find that the answers to your questions are listed in our Frequently Asked Questions Section above.
If you require any further general queries about the Clozagene Study, please see our contact details below:
T: 1800 257 179
A: Locked Bag 2000, Royal Brisbane Hospital, Herston, QLD, 4029, Australia.