The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are: To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy. To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline. To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures. To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology. The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Aged 18 years old or older;

• Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5);

• Treatment resistance according to the Treatment Response and Resistance in Psychosis (TRRIP) Working Group consensus criteria. This requires a PANSS score of more than 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;

• On a stable dose of antipsychotic (no dose changes in the past 1 month);

• 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;

• Capacity to provide informed consent, as judged by an investigator and as assessed by the McArthur scale;

• Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire study.

• Aged 18 years old or older;

• Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5);

• On a stable dose of antipsychotic (no dose changes in the past 1 month);

• 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;

• Capacity to provide informed consent, as judged by an investigator and as assessed by the McArthur scale;

• Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire study.

• Aged 18 years old or older;

• No diagnosis of schizophrenia, schizophreniform or any psychotic disorder;

• Sufficient understanding of the nature of the study and any hazards of participating in it;

• Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire study;

• 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;

• Capacity to provide informed consent, as judged by an investigator.

Locations
Other Locations
United Kingdom
Institute of Psychiatry, Psychology and Neuroscience
RECRUITING
London
Contact Information
Primary
James Scott
james.1.scott@kcl.ac.uk
+44 207 848 0002
Backup
Guy Gitlin-Leigh
guy.1.gitlin-leigh@kcl.ac.uk
Time Frame
Start Date: 2022-11-14
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 288
Treatments
Experimental: Treatment-resistant schizophrenia patients receiving riluzole
No_intervention: Treatment-responsive schizophrenia patients
No_intervention: Healthy controls
Related Therapeutic Areas
Sponsors
Leads: King's College London
Collaborators: South London and Maudsley NHS Foundation Trust

This content was sourced from clinicaltrials.gov

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