Schizophrenia Clinical Trial
Official title:
Anatomical and Structural Connectivity in Schizophrenias
NCT number | NCT02868879 |
Other study ID # | 2898 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 25, 2006 |
Est. completion date | September 2019 |
Verified date | October 2019 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria (controls): - 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: - Current substance abuse - Contraindication to MRI - Past records susceptible to affect brain integrity - Severe, unstable medical condition - Pregnancy - Patients deprived of their rights |
Country | Name | City | State |
---|---|---|---|
France | Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
Subjects will be assessed only once. |
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