Cognitive and Affective Symptoms in Schizophrenia Intervention (CASSI) Trial
Of all the various symptoms associated with schizophrenia, impairments to cognition function are generally resistant to full remission and are the most lasting and debilitating as they interfere with the ability to function independently.
This study aims to provide;
1) a means to determine if the estrogen receptor type 1 genotype can be linked to specific cognitive deficits in patients with schizophrenia; and
2) a means to reverse cognitive deficits in patients with schizophrenia.
This research project will be in partnership with the Kiloh Centre at the Prince of Wales Hospital and future work with the clinical population is planned to enhance the translational work from the Chair's laboratory.
To enrol in the study or find out further information, please contact:
Nicholas Vella
Tel: +612 9399 1683
Fax: +612 9399 1034
E-mail: n.vella@neura.edu.au
FAQs
Who can enrol?
Patients with schizophrenia (see below).
What will I do?
You will help us determine if taking an additional pill (hormone modulator or SERM) can improve symptoms and thought processes and emotional responses.
Will it cost me money?
Reimbursement will be provided for out-of-pocket expenses, such as travel to the centre, which will amount to a total of $60.00 per visit.
You can participate if:
- 1. You are a male or female patients with schizophrenia
- 2. You are between the ages of 18 and 50
- 3. You have been on antipsychotic medication for at least one year
Sorry, but you are not able to enrol if you have any of the following:
- another psychiatric diagnosis
- head injury with loss of consciousness
- seizures
-
central nervous system infection
- lactose intolerance
- pain and inflammation in a vein just under the skin
- blood clotting disease
- congestive heart failure
- reactions to raloxifene
- you are pregnant
How does the SERM work?
- Hormonal modulators (SERMs) will be used to stimulate the oestrogen receptors in the brain and to help the brain function normally in male and female patients with schizophrenia.
Why have I been invited to participate in this study?
- You were selected as a possible participant in this study because you are a patient with schizophrenia who could help us determine whether a SERM can improve thinking problems in patients with schizophrenia.
What if I do not want to take part in the study or I want to withdraw later?
- Participation in this study is completely voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect any treatment you receive now or later. If you wish to leave the study after you begin, you can do so at any time without have to give a reason.
What does the study involve?
- This study will be conducted over 13 weeks.
- If you agree to participate, you will then be asked to make 4 visits to our clinic.
First visit (7 hours)
- Complete paper and pencil tests of your thinking abilities and respond to questions about your symptoms and daily activities.
- Have a blood sample taken to identify your oestrogen receptor genotype and blood clotting levels. We will check to see if you are pregnant if you are a female.
- Brief medical/clinical interview with study doctors to discuss current medical state and any potential side effects.
- Receive an optional MRI scan of your brain measuring your brain activity while you perform a computerized test.
- What to expect when you have your MRI - information guide
While at home
- Take an oral daily dose of either raloxifene 120mg (the active SERM) or a placebo for 6 weeks along with your antipsychotic medication. Receive weekly phone calls from psychologist or doctor.
Second visit (6 weeks after initial, 5 hours):
- All the same tests, assessments and interviews listed under the first visit, including:
- blood sample
- MRI scan
- cognitive tests
Third visit (one week after second visit):
- You will be required to come in to pick up the remaining medication. You will then enter the second part of the study in which you will take an oral daily dose of the other treatment (raloxifene 120mg or placebo) along with your antipsychotic medication for 6 weeks.
Fourth visit (6 weeks after third visit, 5 hours):
- All the same tests, assessments and interviews listed under the initial visit.
