None listed
Conditions
Brief summary
This research study will use medication to try to improve language, memory, and symptoms in schizophrenia. This medication (called canakinumab) is used to reduce harmful by-products of infection. We hope to learn how this medication in addition to antipsychotic medication can improve thinking and reduce symptoms in people with schizophrenia and to determine if this medication can be used as a new treatment for thinking problems and symptoms in people with schizophrenia.
Interventions
Canakinumab 180 mg subcutaneous injection will be administered once and lasts for up to 8 weeks as an adjunctive treatment to each participant's usual antipsychotic treatment by one of our study physicians who will be blind to treatment condition.
Sponsors
Neuroscience Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
diagnosis of schizophrenia or schizoaffective disorder between 18 and 55 years of age have been receiving antipsychotic medication for at least 1 year display elevated neutrophil to lymphocyte ratio greater than 2 or an elevated IL-1beta ELISA assay
Exclusion criteria
concurrent DSM-V axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder display a neutrophil to lymphocyte ratio less than 2 or display normal IL-1beta ELISA levels history of current substance abuse or dependence (within the past 3 years) head injuries with loss of consciousness seizures central nervous system infection untreated diabetes or hypertension mental retardation learning disorder history of pervasive developmental disorder present systemic infections history of recurrent infections have been recently administered live vaccines neutropenia (defined by neutrophil count) positive pregnancy blood test lactating intends to become pregnant refuses to use contraception or remain abstinent till 1 month after the study history of causing harm to self or others receiving tumor necrosis factor inhibitors receiving clozapine hypersensitivity or contraindications to canakinumab
Outcome results
None listed