SSBC Research Study
What is a research study?
A research study is an effort by scientists to understand something that we don’t know enough about – for example, questions about the underlying causes of mental illnesses. Some research studies recruit people to volunteer as participants. The choice to participate in a research study is completely voluntary – participants may initially agree to participate in a research study and can later change their mind and choose to withdraw from the study at any point.
What is SSBC?
The Schizophrenia Spectrum Biomarkers Consortium (SSBC) is an international collaboration with the collective goal of identifying biomarkers in schizophrenia and related disorders. The SSBC was established in 2018 and consists of a number of universities, research institutions, and partners such as the National Alliance on Mental Illness (NAMI).
What is the SSBC research study?
The SSBC research study is designed to identify biological markers for schizophrenia and related mental illnesses. Schizophrenia is a brain-based mental illness that may include experiences that seem out of touch with reality, disorganized speech or behavior, and decreased participation in daily activities. Difficulty with concentration and memory may also occur. Identifying biological markers – such as proteins, hormones, and brain activity patterns – can help us understand more about how schizophrenia develops and how it affects different people. This research study could ultimately help us treat schizophrenia more effectively.
Who can participate in the SSBC research study?
We are currently enrolling participants who:
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Have been diagnosed with a schizophrenia-spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder), and are aged 18-50 years
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Are at clinical high risk for schizophrenia, and are aged 18-40 years
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Are healthy (without a diagnosis or clinical high risk), and are aged 18-50 years
Where is the SSBC research study taking place?
Current research study sites are:
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Icahn School of Medicine at Mount Sinai, New York, NY
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Perelman School of Medicine at UPenn, Philadelphia, PA
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Yale School of Medicine, New Haven, CT
How can I volunteer to participate in the SSBC research study?
If you are 18 years or older and interested in participating in this study or need more information, please visit our Educational Resources page or you can contact ssbc@iu.edu.
If you live close to one of our study sites in New York City, Philadelphia or New Haven, you can also contact your local study team directly. For contact information, please visit the study sites page.
My family member might be eligible to participate. How can I learn more?
You can find more information about the SSBC study on our Educational Resources page or you can contact ssbc@iu.edu for further questions. If your family member is interested in participating in the SSBC study, they can reach out to our study sites to register for the study.
Participating in the SSBC Study
Who can participate in the SSBC research study?
We are currently enrolling participants who:
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Have been diagnosed with a schizophrenia-spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder), and are aged 18-50 years
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Are at clinical high risk for schizophrenia, and are aged 18-40 years
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Are healthy (without a diagnosis or clinical high risk), and are aged 18-50 years
How many people will participate in the SSBC research study?
We plan to enroll at least 45 participants in this study per year.
How long will the SSBC research study run?
Participants can be part of this study for up to three years but may choose to participate for a shorter amount of time.
What does participation in the SSBC research study involve?
Participants in this study will be asked to complete:
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Questionnaires about life experiences and medical history
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A brief physical exam
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Neurological assessment
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Neuroimaging (brain imaging)
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Collection of blood and urine samples
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Collection of cerebrospinal fluid (CSF) via lumbar puncture (LP)
Are there any costs to participants?
No – there are no costs associated with any procedure as part of this study. Participants will also be reimbursed for travel expenses.
Will there be compensation for participating in this research?
Yes – participants will receive compensation after each procedure and assessment that is completed. Participants who complete all procedures and assessments within a specific study phase will also receive additional compensation.
Where is the SSBC research study taking place?
Current research study sites are:
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Icahn School of Medicine at Mount Sinai, New York, NY
-
Perelman School of Medicine at UPenn, Philadelphia, PA
-
Yale School of Medicine, New Haven, CT
How can I volunteer to participate in the SSBC research study?
If you are 18 years or older and interested in participating in this study or need more information, please visit our Educational Resources page or you can contact ssbc@iu.edu.
If you live close to one of our study sites in New York City, Philadelphia or New Haven, you can also contact your local study team directly. For contact information, please visit the study sites page.
SSBC Study Procedures
What does participation in the SSBC research study involve?
Participants in this study will be asked to complete:
-
Questionnaires about life experiences and medical history
-
A brief physical exam
-
Neurological assessment
-
Neuroimaging (brain imaging)
-
Collection of blood and urine samples
-
Collection of cerebrospinal fluid (CSF) via lumbar puncture (LP)
What is Neuroimaging?
Neuroimaging, or magnetic resonance imaging (MRI), is a way to take detailed pictures of the brain. During an MRI, the participant lies down on a movable table that slides into a doughnut-shaped scanning machine. To take pictures of the brain, only the participant’s head needs to be inside the scanning machine. The machine acts like a camera – it contains a circular magnet, using a strong magnetic field to produce images of the brain.
Is Neuroimaging painful?
MRI scans are not painful and have very few health risks. Some participants may feel claustrophobia during the procedure, but the study doctors can work to make them more comfortable.
What is cerebrospinal fluid (CSF) and why is it important?
Cerebrospinal fluid (CSF) is a clear liquid produced within the brain which surrounds both the brain and the spinal cord. The body generates new CSF every day. The brain also produces proteins – biological “building blocks” – which are released into the CSF. Just like blood tests are used to measure proteins that are circulating in the blood, the SSBC research study will collect CSF to measure proteins made by the brain. This may help us learn what happens in the brain when individuals develop some mental illnesses.
What is a lumbar puncture (LP)?
CSF can be collected by a procedure known as a lumbar puncture (LP). During an LP, the participant lies down or sits in a hunched-over position and a neurologist – a highly trained specialist doctor – inserts a thin needle in the lower back to collect a small amount of spinal fluid. After the lumbar puncture, the participant rests for 30 minutes so a clinical specialist can make sure they are feeling well. The body produces additional CSF to replace the fluid that is removed.
Is a lumbar puncture painful?
Participants may feel some discomfort during a lumbar puncture. At the beginning of the procedure, the doctor administers a local anesthetic to help numb a small area of the participant’s lower back. This may cause a brief stinging or burning sensation. Participants may also feel a pressure sensation, and possibly some pain, when the needle is inserted and moved into the correct position.
Are there any risks in receiving a lumbar puncture?
The lumbar puncture is a routine procedure performed by a neurologist – a highly-trained specialist doctor. The doctor uses an “atraumatic needle” which is very thin, reducing the chance of pain during the procedure and the chance of side effects. Most participants do not have side effects, but some can experience a headache after the procedure. The headache usually gets better on its own with rest and hydration. In rare cases, the headache may persist. If a participant does have a persistent headache, the study team will be available for advice and treatment options.
Do all participants receive a lumbar puncture?
Yes – all participants, whether they have a schizophrenia-spectrum diagnosis, are at clinical high risk, or are healthy/without a diagnosis will receive a lumbar puncture. It is important to compare samples of CSF from different participants to learn which proteins, at which levels, are involved in the development and progression of mental illness.
What will be done with the collected samples and data?
Each participant will be assigned a code number. All samples, brain images, and data from questionnaires and assessments will be labelled with this code number – this way, samples and data are stored and analyzed securely without the participant’s name or identifiable information. Only the researchers at the study site will have access to the confidential and secure list which links the code to any personal information.
How can I volunteer to participate in the SSBC research study?
If you are 18 years or older and interested in participating in this study or need more information, please visit our Educational Resources page or you can contact ssbc@iu.edu.
If you live close to one of our study sites in New York City, Philadelphia or New Haven, you can also contact your local study team directly. For contact information, please visit the study sites page.