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Clinical Trials/NCT03996122
NCT03996122
Unknown
Not Applicable

Research of Anatomo-functional Biomarkers in Schizophrenia

University Hospital, Caen1 site in 1 country15 target enrollmentApril 4, 2019
ConditionsSchizophrenia

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).

Registry
clinicaltrials.gov
Start Date
April 4, 2019
End Date
October 4, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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