## Protocol Section
### Identification Module
**NCT ID:** NCT02868879

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

**Official Title:** Anatomical and Structural Connectivity in Schizophrenias

#### Organization Study ID Info
**ID:** 2898
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Strasbourg, France
### Status Module
#### Completion Date
**Date:** 2019-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-10-21

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-09

**Type:** ACTUAL

#### Start Date
**Date:** 2006-09-25

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2016-08-16
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-05
**Study First Submit QC Date:** 2016-08-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Strasbourg, France

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Schizophrenia

- Catatonia

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 162

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Quantitative multiparametric and functional MRI

**Label:** Schizophrenia

#### Arm Group 2

**Intervention Names:**

- Other: Quantitative multiparametric and functional MRI

**Label:** Normal controls.

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Normal controls.

- Schizophrenia

**Description:** 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.

**Name:** Quantitative multiparametric and functional MRI

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Changes in structural and functional connectivity according to the phenotype. Correlation between these changes

**Time Frame:** Subjects will be assessed only once.

#### Secondary Outcomes

**Description:** 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)

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

**Time Frame:** Subjects will be assessed only once.

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Strasbourg

**Country:** France

**Facility:** Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

**Zip:** 67091

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 29559372

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5641

- Name: Catatonia

- Relevance: HIGH

- As Found: Catatonia

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002389

- Term: Catatonia

- ID: D000012559

- Term: Schizophrenia

### Misc Info Module

- Version Holder: 2024-05-24
