Research of Anatomo-functional Biomarkers in Schizophrenia

NCT03996122 | Unknown

• 1 other identifier: 2018-A03281-54
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• functional resonance imaging: resting-state

  Functional connectivity comparison between baseline, month 2 and month 6

  baseline, Month 2 and Month 6

Secondary Outcomes (4)

• BDNF samples

  baseline, Month 2 and Month 6

• functional resonance imaging: ASL

  baseline, Month 2 and Month 6

• anatomical resonance imaging: DTI

  baseline, Month 2 and Month 6

• anatomical resonance imaging: T1

  baseline, Month 2 and Month 6

Study Arms (1)

resistant patients with schizophrenia

Age 18 - 60 years No MRI contraindication

Other: fMRI

Interventions

fMRI OTHER

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

Also known as: BDNF samples

resistant patients with schizophrenia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

resistant schizophrenia or schizoaffective disorder patients

You may qualify if:

• schizophrenia or schizoaffective disorder (DSM 5)
• drug resistance
• written patient approval
• social security number in France
• curator or tutor approval if needed

You may not qualify if:

• pregnancy
• other research participation
• neurological evolution disorder
• no MRI contraindication

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU CAEN Normandie

Caen, Normandy, 14000, France

RECRUITING

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

BDNF samples

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Anaïs Vandevelde, MD

  CHU of Caen, Esquirol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anaïs Vandevelde, MD

CONTACT

0231064422; vandevelde-a@chu-caen.fr

Olivier Etard, MD

CONTACT

0231470200; etard-o@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 24, 2019
• Study Start: April 4, 2019
• Primary Completion: April 4, 2021
• Study Completion: October 4, 2021
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)