Clinical trial NCT03996122: Research of Anatomo-functional Biomarkers in Schizophrenia
Official title: Research of Anatomo-functional Biomarkers in Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: schizo-affective disorder
utra-resistance
clozapine
biomarker
fMRI
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resistant schizophrenia or schizoaffective disorder patients

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).

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

Primary outcomes:
measure: functional resonance imaging: resting-state
timeFrame: baseline, Month 2 and Month 6
Secondary outcomes:
measure: BDNF samples
timeFrame: baseline, Month 2 and Month 6
measure: functional resonance imaging: ASL
timeFrame: baseline, Month 2 and Month 6
measure: anatomical resonance imaging: DTI
timeFrame: baseline, Month 2 and Month 6
measure: anatomical resonance imaging: T1
timeFrame: baseline, Month 2 and Month 6
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU CAEN Normandie
state: Normandie
Study officials:
affiliation: CHU of Caen, Esquirol
name: Anaïs Vandevelde, MD
role: PRINCIPAL_INVESTIGATOR
References: