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Research of Anatomo-functional Biomarkers in Schizophrenia (CLOZAREST)

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ClinicalTrials.gov Identifier: NCT03996122
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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).

Condition or disease Intervention/treatment
Schizophrenia Other: fMRI

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).

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research of Anatomo-functional Biomarkers in Schizophrenia
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : April 4, 2021
Estimated Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
resistant patients with schizophrenia
Age 18 - 60 years No MRI contraindication
Other: fMRI
3 fMRI (TO, Month 2 and Month 6) 3 BDNF samples (TO, Month 2 and Month 6)
Other Name: BDNF samples




Primary Outcome Measures :
  1. functional resonance imaging: resting-state [ Time Frame: baseline, Month 2 and Month 6 ]
    Functional connectivity comparison between baseline, month 2 and month 6


Secondary Outcome Measures :
  1. BDNF samples [ Time Frame: baseline, Month 2 and Month 6 ]
    BDNF concentration comparison between baseline, month 2 and month 6

  2. functional resonance imaging: ASL [ Time Frame: baseline, Month 2 and Month 6 ]
    Cerebral perfusion comparison between baseline, month 2 and month 6

  3. anatomical resonance imaging: DTI [ Time Frame: baseline, Month 2 and Month 6 ]
    Anatomical connectivity comparison between baseline, month 2 and month 6

  4. anatomical resonance imaging: T1 [ Time Frame: baseline, Month 2 and Month 6 ]
    White and gray matter volumetric comparison between baseline, month 2 and month 6


Biospecimen Retention:   Samples Without DNA
BDNF samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
resistant schizophrenia or schizoaffective disorder patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996122


Contacts
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Contact: Anaïs Vandevelde, MD 0231064422 ext +33 vandevelde-a@chu-caen.fr
Contact: Olivier Etard, MD 0231470200 ext +33 etard-o@chu-caen.fr

Locations
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France
CHU CAEN Normandie Recruiting
Caen, Normandie, France, 14000
Contact: Anaïs Vandevelde, MD    231065062 ext +33    vandevelde-a@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Anaïs Vandevelde, MD CHU of Caen, Esquirol
Additional Information:
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03996122    
Other Study ID Numbers: 2018-A03281-54
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
schizo-affective disorder
utra-resistance
clozapine
biomarker
fMRI
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders