NCT02868879

Brief Summary

The different subtypes of Schizophrenia might have a disordered connectivity as their final common pathways. The investigators will use multimodal structural MRI to assess anatomical connectivity on the one side and its functional consequence on functional connectivity on the other side to assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with control subjects. The coherence between structural and functional anomalies will be especially studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2006

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

12.9 years

First QC Date

August 5, 2016

Last Update Submit

October 18, 2019

Conditions

SchizophreniaCatatonia

Outcome Measures

Primary Outcomes (1)

  • Changes in structural and functional connectivity according to the phenotype. Correlation between these changes

    Statistical parametric mapping (SPM) will be applied on quantitative maps : rCBF (ml/100g/min), susceptibility (part per billion), R1, R2, R2\* (all expressed in ms-1), fractional anisotropy (fraction), averaged diffusivity (μm²/sec), macromolecular proton fraction (percentage), cortical thickness (mm), VBM (probability of grey and white matter) and contrast maps (BOLD signal correlation with the anterior cingulate ROI).

    Subjects will be assessed only once.

Secondary Outcomes (1)

  • Changes in rCBF and cognition according to the phenotype. Correlation between the different changes and the symptomatic scales.

    Subjects will be assessed only once.

Study Arms (2)

Schizophrenia

Other: Quantitative multiparametric and functional MRI

Normal controls.

Other: Quantitative multiparametric and functional MRI

Interventions

Quantitative multiparametric and functional MRIOTHER

Structural connectivity assessed in the cortex and the white matter using multimodal quantitative parametric imaging (R1, R2, R2\*, DTI, susceptibility, macromolecular proton fraction, cortical thickness, VBM). Functional connectivity assessed using simple BOLD and combined ASL-BOLD sequences during multiple tasks including motor, language and working memory tasks.

Normal controls.Schizophrenia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Schizophrenia patients (subdivided in periodic catatonia and cataphasia) and normal controls, both having the same procedure.

You may qualify if:

  • Aged from 18-65 Y
  • Right handed
  • Schizophrenia according to the DSM5
  • Either periodic catatonia or cataphasia according to the WKL classification
  • Under stable medication regimen (\> 1M)

You may not qualify if:

  • Current substance abuse
  • Contraindication to MRI
  • Past records susceptible to affect brain integrity
  • Severe, unstable medical condition
  • Pregnancy
  • Patients deprived of their rights

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

  • Foucher JR, Zhang YF, Roser M, Lamy J, De Sousa PL, Weibel S, Vidailhet P, Mainberger O, Berna F. A double dissociation between two psychotic phenotypes: Periodic catatonia and cataphasia. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Aug 30;86:363-369. doi: 10.1016/j.pnpbp.2018.03.008. Epub 2018 Mar 17.

    PMID: 29559372DERIVED

MeSH Terms

Conditions

SchizophreniaCatatonia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 16, 2016

Study Start

September 25, 2006

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)