SchizophreniaCLOZARESTNCT03996122
Research of Anatomo-functional Biomarkers in Schizophrenia
An observational study of Schizophrenia, run by University Hospital, Caen at 1 site in France.
Trial summary
To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- fMRI
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2019to 4 Oct 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: resistant schizophrenia or schizoaffective disorder patients
Who may be able to join
- schizophrenia or schizoaffective disorder (DSM 5)
- drug resistance
- written patient approval
- social security number in France
- curator or tutor approval if needed
Who cannot join
- pregnancy
- other research participation
- neurological evolution disorder
- no MRI contraindication
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU CAEN Normandie
Caen, Normandy, 14000
Anaïs Vandevelde, MD, 231065062 ext. +33, vandevelde-a@chu-caen.fr
About this study
To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, we will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).
Read the detailed description
The identification of biomarkers of ultra-resistance (UR) to treatment in schizophrenia would allow earlier, better adapted and more effective personalized management of these patients, which would improve their functional prognosis.
An early decrease in functional connectivity (FC) between some rest networks has recently been proposed as an UR biomarker by McNabb et al. Nevertheless, clozapine has, among its side effects, a direct cardiac action that profoundly modifies patient's hemodynamics. However, functional brain imaging techniques are based on BOLD effect which is dependent on these hemodynamic parameters. It is therefore not possible to say whether these differences in FC are inherent to the pathology or whether they are related to clozapine instauration which causes hemodynamic changes that may disturb BOLD signal.
To objectify UR biomarkers, investigators propose a longitudinal follow-up of resistant patients, starting before clozapine instauration and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, investigators will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).
- Conditions
- Schizophrenia
- Being tested
- fMRI
- Keywords
- schizo-affective disorder, utra-resistance, clozapine, biomarker, fMRI
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Also called BDNF samples
3 fMRI (TO, Month 2 and Month 6) 3 BDNF samples (TO, Month 2 and Month 6)
| Study group | Role | What they receive |
|---|---|---|
| resistant patients with schizophrenia | Age 18 - 60 years No MRI contraindication Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional resonance imaging: resting-state
Functional connectivity comparison between baseline, month 2 and month 6
Measured: baseline, Month 2 and Month 6
Secondary outcomes (4)
BDNF samples
BDNF concentration comparison between baseline, month 2 and month 6
Measured: baseline, Month 2 and Month 6
functional resonance imaging: ASL
Cerebral perfusion comparison between baseline, month 2 and month 6
Measured: baseline, Month 2 and Month 6
anatomical resonance imaging: DTI
Anatomical connectivity comparison between baseline, month 2 and month 6
Measured: baseline, Month 2 and Month 6
anatomical resonance imaging: T1
White and gray matter volumetric comparison between baseline, month 2 and month 6
Measured: baseline, Month 2 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start4 Apr 2019
- Primary completion4 Apr 2021 (estimated)
- Study completion4 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anaïs Vandevelde, MD, Principal investigator, CHU of Caen, Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996122
- Sponsor's protocol ID
- 2018-A03281-54
- Acronym
- CLOZAREST
- Status last verified
- Jun 2019
- First submitted
- 23 May 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Anatomo-functional Biomarkers in Schizophrenia
- ClinicalTrials.gov ID
- NCT03996122
- Acronym / sponsor ID
- CLOZAREST / 2018-A03281-54
- Conditions
- Schizophrenia
- Keywords
- schizo-affective disorder, utra-resistance, clozapine, biomarker, fMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 4 Apr 2021 (estimated)
- Study completion
- 4 Oct 2021 (estimated)
- First posted
- 24 Jun 2019 (actual)
- 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.
To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, we will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).
Detailed description
The identification of biomarkers of ultra-resistance (UR) to treatment in schizophrenia would allow earlier, better adapted and more effective personalized management of these patients, which would improve their functional prognosis.
An early decrease in functional connectivity (FC) between some rest networks has recently been proposed as an UR biomarker by McNabb et al. Nevertheless, clozapine has, among its side effects, a direct cardiac action that profoundly modifies patient's hemodynamics. However, functional brain imaging techniques are based on BOLD effect which is dependent on these hemodynamic parameters. It is therefore not possible to say whether these differences in FC are inherent to the pathology or whether they are related to clozapine instauration which causes hemodynamic changes that may disturb BOLD signal.
To objectify UR biomarkers, investigators propose a longitudinal follow-up of resistant patients, starting before clozapine instauration and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, investigators will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| resistant patients with schizophrenia | – | Other: fMRIAge 18 - 60 years No MRI contraindication |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- resistant schizophrenia or schizoaffective disorder patients
Key inclusion criteria (5 listed)
- schizophrenia or schizoaffective disorder (DSM 5)
- drug resistance
- written patient approval
- social security number in France
- curator or tutor approval if needed
Key exclusion criteria (4 listed)
- pregnancy
- other research participation
- neurological evolution disorder
- no MRI contraindication
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 |
|---|---|---|
| fMRIAlso: BDNF samples3 fMRI (TO, Month 2 and Month 6) 3 BDNF samples (TO, Month 2 and Month 6) | Other | resistant patients with schizophrenia |
Primary outcome
functional resonance imaging: resting-state
Time frame: baseline, Month 2 and Month 6
Functional connectivity comparison between baseline, month 2 and month 6
4 secondary outcomes
BDNF samples
Time frame: baseline, Month 2 and Month 6
functional resonance imaging: ASL
Time frame: baseline, Month 2 and Month 6
anatomical resonance imaging: DTI
Time frame: baseline, Month 2 and Month 6
anatomical resonance imaging: T1
Time frame: baseline, Month 2 and Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Abnormalities of fronto-subcortical pathways in schizophrenia and the differential impacts of antipsychotic treatment: a DTI-based tractography studyLink provided by the sponsor.
- Functional network dysconnectivity as a biomarker of treatment resistance in schizophreniaLink provided by the sponsor.
- 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.
Anaïs Vandevelde, MD principal investigator
CHU of Caen, Esquirol
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, run by University Hospital, Caen 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Vandevelde, MD (0231064422 ext. +33, vandevelde-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional resonance imaging: resting-state (time frame: baseline, Month 2 and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2019.