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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Oliver
Howes
oliver.howes@kcl.ac.uk
Guy
Gitlin-Leigh
guy.1.gitlin-leigh@kcl.ac.uk
Schizophrenia, schizotypal and delusional disorders
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Schizophrenia is a common,severe and disabling psychiatric illness affecting approximately 1% of people. It is amongst the top ten causes of disability in adults in the world. Many patients do not respond to standard (non-clozapine) antipsychotic medications and this is termed treatment-resistant schizophrenia (TRS). Studies suggest that TRS is present in approximately 30% of patients but rates can be even higher. Currently,clozapine is the only drug licensed to treat TRS,but its use is significantly limited by its side effects in up to ~50% of patients,and the majority of TRS patients are either unable or unwilling to start clozapine. Several lines of evidence indicate that patients with TRS may have higher levels of the brain chemical glutamate. However,the exact nature of glutamate dysfunction in patients with TRS remains unclear. The aim of this study is to investigate the levels of glutamate in patients with TRS by measuring levels of glutamate in the brain and other brain markers associated with this chemical (e.g brain blood flow,structure,and function) and to compare these measures with healthy controls and patients whose symptoms respond to medication (treatment responders) to determine if there is a difference between the different groups. We plan to do this using brain scans or more specifically Magnetic Resonance imaging (MRI). In addition,we will examine if Riluzole,a medication known to reduce glutamate levels,is able to reduce glutamate levels in patients with TRS and if changes in glutamate are associated with changes in the symptoms the patients experience. We will recruit people with a diagnosis of schizophrenia from the South London and Maudsley NHS Foundation Trust and healthy participants from the local community. This study will take place at the Institute of Psychiatry,Psychology and Neuroscience King’s College London over a 5 year period.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Exclusion criteria for treatment-resistant schizophrenia patients 1.History of significant co-morbid CNS disorder (including significant head trauma or significant loss of consciousness,Parkinson’s Disease,Epilepsy,Alzheimer’s Dementia,Huntington’s Disease); 2.Current use of medication with recognized effect on glutamatergic signaling (e.g. lamotrigine,lithium,carbamazepine,opiates,and psychostimulants) OR medication that is known to interact with Riluzole (eg: ciprofloxacin,combined hormonal contraceptives,enoxacin,fluvoxamine,charcoal boiled (grilled) foods,methoxasalen,rucaparib,osilodrostat,mexiletine,nicergoline,pipemidic acid,rifampicin,tiabendazole,vemurafenib); 3.Any absolute contra-indication to riluzole according to the British National Formulary (such as interstitial lung disease,current pregnancy or lactation,severe hepatic impairment LFTs> 3x Upper limit of normal,acute porphyria,pancreatitis); 4.Pregnancy and/or breast-feeding; 5.Substance dependence/abuse other than to cigarettes; 6.Current high suicide risk or other significant safety risk as judged by the patient’s psychiatrist or study physician; 7.Current homicidal ideation or intent; 8.Participation in a clinical study of unlicensed medicines within the previous 30 days; 9.Clinically relevant abnormal findings at the screening assessment as judged significant by the principal investigator (e.g.: history of liver disease or transaminases > 2 times the upper limit of normal); 10.Presence of other acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the study or raise safety concerns; 11.Any risk factors for liver damage (eg. alcohol dependence or history of liver disease) or patients who are receiving potentially hepatotoxic medications; 12.Likelihood that the subject will not comply with study requirements or other reason the investigator judges the subject is not suitable; 13.Objection by subject’s physician; 14.Any contraindication to MRI scanning (e.g. metallic implants); 15.Any comorbidity that could compromise scanning safety (e.g. severe asthma). Exclusion criteria for treatment-responsive schizophrenia patients 1.Treatment resistance according to the Treatment Response and Resistance in Psychosis (TRRIP) Working Group consensus criteria; 2.History of significant co-morbid CNS disorder (including significant head trauma or significant loss of consciousness,Parkinson’s Disease,Epilepsy,Alzheimer’s Dementia,Huntington’s Disease); 3.Substance dependence/abuse other than to cigarettes; 4.Current high suicide risk or other significant safety risk as judged by the patient’s psychiatrist or study physician; 5.Current homicidal ideation or intent; 6.Participation in a clinical study of unlicensed medicines within the previous 30 days; Exclusion criteria for healthy controls 1.Co-morbid psychiatric or other CNS disorder; 2.Family history of Schizophrenia or Psychotic disorders; 3.History of head trauma or loss of consciousness; 4.Substance dependence/abuse other than to cigarettes; 5.Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the study or make it unnecessarily hazardous and judge significant by the principal investigator; 6.Likelihood that the volunteer will not comply with the requirements of the study or other reason the investigator judges the subject is not suitable; 7.Objection by a General Practitioner (GP),or another doctor responsible for their treatment,to the healthy control entering study.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by King's College London and funded by Medical Research Council (MRC) .
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Read full details
for Trial ID: CPMS 55171
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