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Research of Anatomo-functional Biomarkers in Schizophrenia

Research of Anatomo-functional Biomarkers in Schizophrenia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03996122
Acronym
CLOZAREST
Enrollment
15
Registered
2019-06-24
Start date
2019-04-04
Completion date
2021-10-04
Last updated
2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizo-affective disorder, utra-resistance, clozapine, biomarker, fMRI

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).

Interventions

OTHERfMRI

3 fMRI (TO, Month 2 and Month 6) 3 BDNF samples (TO, Month 2 and Month 6)

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
functional resonance imaging: resting-statebaseline, Month 2 and Month 6Functional connectivity comparison between baseline, month 2 and month 6

Secondary

MeasureTime frameDescription
BDNF samplesbaseline, Month 2 and Month 6BDNF concentration comparison between baseline, month 2 and month 6
functional resonance imaging: ASLbaseline, Month 2 and Month 6Cerebral perfusion comparison between baseline, month 2 and month 6
anatomical resonance imaging: DTIbaseline, Month 2 and Month 6Anatomical connectivity comparison between baseline, month 2 and month 6
anatomical resonance imaging: T1baseline, Month 2 and Month 6White and gray matter volumetric comparison between baseline, month 2 and month 6

Countries

France

Contacts

Primary ContactAnaïs Vandevelde, MD
vandevelde-a@chu-caen.fr0231064422
Backup ContactOlivier Etard, MD
etard-o@chu-caen.fr0231470200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026