RESTORE
Overview
The role of glutamatergic function in the pathophysiology of treatment-resistant schizophrenia (RESTORE)
Research volunteers wanted for a brain scan
You must be aged between 18 and 65
If you are interested please inform your care coordinator or treating doctor, who will contact our research team on your behalf if you are suitable for the study.
Your time and travel expenses will be reimbursed.
Are you interested in taking part in this study?
Planned end date
31 Dec 2024 21:26Conditions
Psychosis,SchizophreniaInclusion Criteria
Inclusion criteria for treatment-resistant schizophrenia patients:
1.> or = to 18 years old
2.Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
3.Treatment resistance according to the Treatment Response and Resistance in Psychosis (TRRIP) Working Group consensus criteria. This requires a PANSS score of >70 and the presence of at least one positive and one negative symptom rated as ≥ 4 on the Positive and Negative Syndrome Scale (PANSS) and at least moderate functional impairment on the Social and Occupational Function Assessment Scale (SOFAS) despite at least 2 adequate trials of different antipsychotics
4.On a stable dose of antipsychotic (no dose changes in the past 1 month)
5.Able to give fully informed written consent and likely to comply with the requirements of the study,after reading the information and consent form,and after having the opportunity to discuss the study with the investigator or his delegate.
6.Capacity to provide informed consent,as judged by an investigator and as assessed by the McArthur scale.
7.Ability to communicate satisfactorily with the investigator and to participate in,and comply with the requirements of the entire study.
Inclusion criteria for healthy controls
1.Aged > or =18 years
2.No diagnosis of schizophrenia,schizophreniform or any psychotic disorder.
3.Sufficient understanding of the nature of the study and any hazards of participating in it.
4.Ability to communicate satisfactorily with the investigator and to participate in,and comply with the requirements of the entire study.
5.Willingness to give written consent to participate after reading the information and consent form,and after having the opportunity to discuss the study with the investigator or his delegate.
6.Capacity to provide informed consent,as judged by an investigator.
Inclusion criteria for treatment-responsive schizophrenia patients
1.Aged > or =18 years
2.Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
3.On a stable dose of antipsychotic (no dose changes in the past 1 month).
4.Able to give fully informed written consent and likely to comply with the requirements of the study,after reading the information and consent form,and after having the opportunity to discuss the study with the investigator or his delegate.
5.Capacity to provide informed consent,as judged by an investigator and as assessed by the McArthur scale.
6.Ability to communicate satisfactorily with the investigator and to participate in,and comply with the requirements of the entire study.
Exclusion Criteria
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.
