Research of Anatomo-functional Biomarkers in Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- University Hospital, Caen
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- functional resonance imaging: resting-state
- Last Updated
- 6 years ago
Overview
Brief Summary
To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, we will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).
Detailed Description
The identification of biomarkers of ultra-resistance (UR) to treatment in schizophrenia would allow earlier, better adapted and more effective personalized management of these patients, which would improve their functional prognosis. An early decrease in functional connectivity (FC) between some rest networks has recently been proposed as an UR biomarker by McNabb et al. Nevertheless, clozapine has, among its side effects, a direct cardiac action that profoundly modifies patient's hemodynamics. However, functional brain imaging techniques are based on BOLD effect which is dependent on these hemodynamic parameters. It is therefore not possible to say whether these differences in FC are inherent to the pathology or whether they are related to clozapine instauration which causes hemodynamic changes that may disturb BOLD signal. To objectify UR biomarkers, investigators propose a longitudinal follow-up of resistant patients, starting before clozapine instauration and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, investigators will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).
Investigators
Eligibility Criteria
Inclusion Criteria
- •schizophrenia or schizoaffective disorder (DSM 5)
- •drug resistance
- •written patient approval
- •social security number in France
- •curator or tutor approval if needed
Exclusion Criteria
- •pregnancy
- •other research participation
- •neurological evolution disorder
- •no MRI contraindication
Outcomes
Primary Outcomes
functional resonance imaging: resting-state
Time Frame: baseline, Month 2 and Month 6
Functional connectivity comparison between baseline, month 2 and month 6
Secondary Outcomes
- BDNF samples(baseline, Month 2 and Month 6)
- functional resonance imaging: ASL(baseline, Month 2 and Month 6)
- anatomical resonance imaging: T1(baseline, Month 2 and Month 6)
- anatomical resonance imaging: DTI(baseline, Month 2 and Month 6)