Research of Anatomo-functional Biomarkers in Schizophrenia | NCT03996122

Studies
Research of Anatomo-functional Biomarkers in Schizophrenia

NCT03996122

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Jun 24, 2019Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Schizophrenia

Interventions

fMRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2019Actual

Primary Completion Date

Apr 4, 2021Estimated

Completion Date

Oct 4, 2021Estimated

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

Jun 21, 2019

First Posted Date

Jun 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2019

Last Update Posted Date

Jun 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
resistant patients with schizophrenia		Age 18 - 60 years No MRI contraindication	Other: fMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI	Other	3 fMRI (TO, Month 2 and Month 6) 3 BDNF samples (TO, Month 2 and Month 6)	resistant patients with schizophrenia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional resonance imaging: resting-state	Functional connectivity comparison between baseline, month 2 and month 6	baseline, Month 2 and Month 6

Secondary Outcomes

Measure	Description	Time Frame
BDNF samples	BDNF concentration comparison between baseline, month 2 and month 6	baseline, Month 2 and Month 6
functional resonance imaging: ASL	Cerebral perfusion comparison between baseline, month 2 and month 6

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

resistant schizophrenia or schizoaffective disorder patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anaïs Vandevelde, MD	Contact	0231064422	+33	vandevelde-a@chu-caen.fr
Olivier Etard, MD	Contact	0231470200	+33	etard-o@chu-caen.fr

Overall Officials

Name	Affiliation	Role
Anaïs Vandevelde, MD	CHU of Caen, Esquirol	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU CAEN Normandie	Recruiting	Caen	Normandy	14000	France

References Module

Citations

Not provided

Label	URL
Abnormalities of fronto-subcortical pathways in schizophrenia and the differential impacts of antipsychotic treatment: a DTI-based tractography study	View source
Functional network dysconnectivity as a biomarker of treatment resistance in schizophrenia	View source

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders