Canakinumab Add-on Treatment for Schizophrenia (CATS) Study
Canakinumab adjunctive treatment to reduce symptoms and improve cognition in people with schizophrenia displaying elevated blood inflammatory markers
HREC Approval Number: 14/072
What is the purpose of this study?
You are invited to participate in a research study of a human immune cell-line antibody on language, memory, and symptoms of schizophrenia. This human immune cell-line antibody, canakinumab, is a class of medication that decreases the levels of the protein interleukin-1beta (IL-1β). The IL-1β protein is produced in response to inflammation in your body and canakinumab can decrease IL-1β protein and inflammation by blocking the pathway. We hope to learn how this human immune cell-line antibody, in addition to your normal antipsychotic medication, can also improve thought processing and reduce symptoms in people with schizophrenia, and to determine if this human immune cell-line antibody can be used as a new therapeutic treatment for thinking problems and symptoms in people with schizophrenia.
What does the study involve?
The study involves a one-time injection of canakinumab or placebo and 6 monitoring assessment visits over a 4-month period. The assessments include:
- An in-person screening interview
- Cognitive tests
- Symptom assessments
- Medical examinations and clinical interviews
- Blood collection
- Structural and functional MRI
Who can enrol?
Men or women age 18-55 years old with a diagnosis of schizophrenia or schizoaffective disorder. You must be taking antipsychotic medication for at least one year but you must not be taking clozapine and have no other psychiatric diagnoses, history of seizures, substance abuse (within past 3 years), head injury or loss of consciousness, central nervous system infections or other serious or chronic infections, and if a woman, you cannot be pregnant.
Will I be reimbursed?
Your participation in this study may have associated expenses. Reimbursement will be provided for your time and for out-of-pocket expenses, such as travel to the centre.
If you have any questions, or if you are interested in participating, please feel free to contact a member of the research team:
Isabella Jacomb at 02 9399 1858, email: firstname.lastname@example.org
Dr Thomas W Weickert at 02 9399 1730, fax: 02 9399 1034, email: email@example.com