An observational study in Schizophrenia and Schizoaffective Disorder, sponsored by The Royal Ottawa Mental Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by The Royal Ottawa Mental Health Centre · Observational
The goal of this research project is to develop MRI-based biomarkers to identify patients with schizophrenia who are most likely to benefit from first-line antipsychotic or clozapine treatment. The MRI sequences (NM-MRI, MRS and rsfMRI) will be created by translating the best scientific evidence into a potential clinical product that has the highest chance of being clinically relevant predictor of treatment response. This study has the potential to significantly improve patient outcomes and reduce unnecessary interventions and costs at the Royal's Integrated Schizophrenia Recovery Program.
Currently, we cannot predict who will get better on first-line antipsychotic versus clozapine treatment. Although much evidence shows that dopamine and glutamate function are related to treatment response in schizophrenia, the utility of neuromelanin sensitive MRI (NM-MRI) as a measure of dopamine and magnetic resonance spectroscopy (MRS) as a measure of glutamate \& glycine (a co-agonist of glutamate receptors) in predicting response to treatment have never been measured in the same sample. The evidence suggests that the function of these two neurotransmitter systems partially determines the response to antipsychotic medications. Additionally, an emerging type of resting-state functional MRI (rsfMRI), naturalistic movie-watching, has been shown to outperform traditional rsfMRI for functional connectivity-based prediction of behaviour and will be explored in the current study. Given the background information, our hypotheses are:
1.1) First-line antipsychotic users will have higher dopamine turnover resulting in a higher NM-MRI signal in the substantia nigra relative to clozapine users.
1.2) First-line antipsychotic users will have lower glutamate and/or glycine concentration as indicated by the MRS signal in the dorsal anterior cingulate relative to clozapine users.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 40 is below the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →The Royal Ottawa Mental Health Centre is the lead sponsor of 22 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals with a diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
This group will consist of 20 patients with schizophrenia or schizoaffective disorder who are primarily prescribed olanzapine. Treatment will be carried out by the physicians within their circle of care, however, we will record their symptoms as they continue treatment.
Drug: Olanzapine
This group will consist of 20 patients with schizophrenia or schizoaffective disorder who are primarily prescribed clozapine due to poor treatment response to first-line antipsychotic agents. Treatment will be carried out by the physicians within their circle of care, however, we will record their symptoms as they continue treatment.
Drug: Clozapine
Antipsychotic medication
Also known as: Zyprexa
Antipsychotic medication
Also known as: Clozaril
Neuromelanin-sensitive magnetic resonance imaging (MRI) contrast-to-noise ratio (CNR)
Indexes dopamine function
Time frame: Will be examined cross-sectionally on an as-recruited basis.
Glutamate/glycine magnetic resonance sptrectroscopy (MRS)
Indexes glutamate \& glycine concentration
Time frame: Will be examined cross-sectionally on an as-recruited basis.
Plan to share: No — IPD will not be shared.
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The Royal Ottawa Mental Health Centre