SchizophreniaNCT02868879
Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia
An observational study of Schizophrenia and Catatonia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Catatonia
- What is being tested?
- Quantitative multiparametric and functional MRI
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2006to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Schizophrenia patients (subdivided in periodic catatonia and cataphasia) and normal controls, both having the same procedure.
Who may be able to join
- 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)
Who cannot join
- Current substance abuse
- Contraindication to MRI
- Past records susceptible to affect brain integrity
- Severe, unstable medical condition
- Pregnancy
- Patients deprived of their rights
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Anatomical and Structural Connectivity in Schizophrenias
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
- Schizophrenia, Catatonia
- Being tested
- Quantitative multiparametric and functional MRI
- Medical subject headings
- Schizophrenia, Catatonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Not described Receives: Other: Quantitative multiparametric and functional MRI | |
| Normal controls. | Not described Receives: Other: Quantitative multiparametric and functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Subjects will be assessed only once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start25 Sep 2006
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868879
- Sponsor's protocol ID
- 2898
- Status last verified
- Oct 2019
- First submitted
- 5 Aug 2016
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Structural Connectivity in Schizophrenias
- ClinicalTrials.gov ID
- NCT02868879
- Acronym / sponsor ID
- 2898
- Conditions
- Schizophrenia, Catatonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 25 Sep 2006 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | Other: Quantitative multiparametric and functional MRI |
| Normal controls. | – | Other: Quantitative multiparametric and functional MRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenia patients (subdivided in periodic catatonia and cataphasia) and normal controls, both having the same procedure.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- Current substance abuse
- Contraindication to MRI
- Past records susceptible to affect brain integrity
- Severe, unstable medical condition
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative multiparametric and functional MRIStructural 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. | Other | Normal controls., Schizophrenia |
Primary outcome
Changes in structural and functional connectivity according to the phenotype. Correlation between these changes
Time frame: Subjects will be assessed only once.
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 29559372Foucher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Catatonia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in structural and functional connectivity according to the phenotype. Correlation between these changes (time frame: Subjects will be assessed only once.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.