ClinicalTrials.gg
CompletedNCT02868879Updated Oct 21, 2019

Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia

An observational study in Schizophrenia and Catatonia, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
162
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Schizophrenia
  • Catatonia
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In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's enrollment of 162 is close to the median of 178 across 506 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged from 18-65 Y
  • Right handed

Additional inclusion criteria for patients:

  • Schizophrenia according to the DSM5
  • Either periodic catatonia or cataphasia according to the WKL classification
  • Under stable medication regimen (> 1M)

Exclusion criteria

Exclusion criteria:

  • Current substance abuse
  • to MRI
  • Past records susceptible to affect brain integrity
  • Severe, unstable medical condition
  • Pregnancy
  • Patients deprived of their rights
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
162 participants (actual)
Patient registry
No

Groups and cohorts

  • Schizophrenia

    Other: Quantitative multiparametric and functional MRI

  • Normal controls.

    Other: Quantitative multiparametric and functional MRI

Interventions

  • OtherQuantitative multiparametric and functional MRI

    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.

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What researchers measure

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).

    Time frame: 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.

    Symptomatic scales : PANSS, SANS, SAPS, Calgary, Bush and Francis catatonia scale, the psychological experimental test operationalized for cataphasia, Clinician-rated dimension of psychosis symptom severity questionnaire assessing handedness, anhedonia, vigilance, QoL, activity, handicap, ruminations, depression and personality. Cognitive tests : grammar tests, semantic priming, implicit memory, CPT, fNART, Mill-Hill (part B)

    Time frame: Subjects will be assessed only once.

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Study locations

1 site
  • Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
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References and documents

Publications

  • 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. PubMed 29559372 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2006 to primary completion in Sep 2019, 156 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2016
First posted
Aug 16, 2016
StartActual
Sep 25, 2006
Primary completionActual
Sep 2019
CompletionActual
Sep 2019
Last update
Oct 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02868879
Responsible party
Sponsor
First posted
Aug 16, 2016
Start date
Sep 25, 2006
Primary completion
Sep 2019
Completion
Sep 2019
Last update
Oct 21, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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