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

Early Phase 1

Recruiting

• Conditions: Treatment-resistant Schizophrenia; Treatment-responsive Schizophrenia; Healthy Controls
• Interventions: Drug: Riluzole

• Registration Number: NCT06270108
• Lead Sponsor: King's College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-resistant schizophrenia patients receiving riluzole	Riluzole	-

Primary Outcome Measures

Name	Time	Method
Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration	Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days)	Change in glutamate levels will be assessed (using magnetic resonance spectroscopy) in treatment-resistant schizophrenia patients compared with controls and patients without treatment-resistant schizophrenia

Secondary Outcome Measures

Name	Time	Method
Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging)	Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days)
Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology	Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days)	Changes in psychopathology assessed using rating scales Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression scale (CGI), Calgary Depression Scale for Schizophrenia (CDSS), Montgomery and Asberg Depression Rating Scale (MADRS), Hopkins Verbal Learning Test (HVLT) and a computerised cognitive task
Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging)	Brain measurements will be conducted at baseline (day -7 to day -1 before riluzole administration), day 7 and day 56 (+- 14 days)

Trial Locations

Locations (1)

Institute of Psychiatry, Psychology and Neuroscience; 🇬🇧 London, United Kingdom