SchizophreniaSCHIZO'TRAUMANCT03355781
Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology
An observational study of Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers, these adversities are linked to a decrease of grey matter of the brain, similar to those observed in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- magnetic resonance imaging (MRI), Blood sample and Clinical psychiatric evaluation
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2018to 30 Nov 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Schizophrenic patients, related volunteers (first degree relative of patient) and healthy volunteers
Who may be able to join
- For women with reproductively active age period: suitable contraceptive method and negative pregnancy test
- Schizophrenia diagnosis (according to DSM 5)
- Regular follow-up care at hospital
- No change in antipsychotic medication (medication AND dosage) within at least six weeks
- Patient into remission : constant dosage, out-patient and meeting Andreassen criteria
- Who have given their informed consent before participating in the study.
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- Physical examination without significant clinical physical anomaly
- No serious somatic pathology
- Affiliates or entitled to a social security scheme
- Age, gender and socio-educational level similar to recruited patients
- Who have given their informed consent before participating in the study.
- First degree relative of schizophrenic patient diagnosed according DSM IV criteria
- No schizophrenia diagnosis according DSM IV criteria
- No psychiatric history and free of psychotropic drugs/treatment
- Physical examination without significant clinical anomaly
- Affiliates or entitled to a social security scheme
- Age, gender and socio-educational level similar to recruited patients
- Who have given their informed consent before participating in the study.
- No schizophrenia diagnosis according DSM IV criteria
- No personal or family history of psychiatric disorders
- Free of psychotropic drugs/treatment
- Physical examination without significant clinical anomaly
- Affiliates or entitled to a social security scheme
Who cannot join
- For women with reproductively active age period: no suitable contraceptive method (oral, hormonal, intramuscular, intrauterine device, or surgical)
- Pregnancy or breastfeeding
- Not meeting schizophrenic criteria according to DSM 5 or presenting resistant schizophrenic criteria according Kane criteria
- Presenting a serious somatic disorder or neurological (particularly Parkinson disease, epilepsy, tardive dyskinesia)
- Cardiovascular, hepatic or serious renal diseases
- Contraindication to MRI examination, particularly ocular or intracranial metallic foreign object,pacemaker, artificial heart valve, surgical clip
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- Claustrophobia, significant tatoo in the high part of the body, IUD incompatible with MRI 3Tesla
- Alcohol or drug addiction, within the last year
- Recruited in other clinical trial or exclusion period from previous trial.
- Susceptibility to self-harm behaviour according to investigator
- For women with reproductively active age period: no suitable contraceptive method (oral, hormonal, intramuscular, intrauterine device, or surgical)
- Pregnancy or breastfeeding
- Presenting somatic, neurological or psychiatric disorder
- Alcohol or drug addiction, within the last year
- Recruited in other clinical trial or exclusion period from previous trial.
- Contraindication to MRI examination, particularly ocular or intracranial metallic foreign object, pacemaker, artificial heart valve, surgical clip
- Claustrophobia, significant tatoo in the high part of the body, IUD incompatible with MRI 3Tesla
- Beside the absence of schizophrenia diagnosis, healthy volunteers should meet the same exclusion criteria as patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology. SCHIZO' TRAUMA
Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers, these adversities are linked to a decrease of grey matter of the brain, similar to those observed in schizophrenia.
In a previous study based on Voxel-Based Morphometry (VBM), including 21 schizophrenic patients and 30 healthy volunteers, the investigators shown a negative correlation between emotional neglect (important dimension in childhood trauma) and grey matter decrease. This strong correlation was significantly higher in schizophrenic patients than in healthy volunteers, suggesting a higher genetic predisposition to environmental factors in schizophrenic people.
Read more
Currently, interaction between genetic predisposition and environmental stress factors is the major model for understanding in schizophrenia. In order to analyze both effects on human body, particularly on brain, several studies currently focus on the product of genetic expression, the ribonucleic acid (ARN).
The purpose of this study is to provide an explanatory model of links between childhood trauma, candidate gene for schizophrenia expression, cerebral morphology and schizophrenic symptomatology. Using conceptual framework of stress vulnerability, structural equation modeling (SEM) will allow testing causal link between these different variables.
- Conditions
- Schizophrenia
- Being tested
- magnetic resonance imaging (MRI), Blood sample, Clinical psychiatric evaluation
- Keywords
- childhood trauma, candidate gene expression, cerebral morphology, schizophrenic symptomatology, conceptual framework of stress vulnerability
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI)Device
brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity
Blood sampleProcedure or surgery
27,5 ml of blood sample : genetic analysis and biobank
Clinical psychiatric evaluationOther
Global Assessment Scale(GAS),Mini International Neuropsychiatric Interview(MINI),Positive and Negative Symptoms Scale(PANSS),Family Interview for Genetic Studies(FIGS),Calgary Depression Scale for Schizophrenia(CDSS),extrapyramidal side effects evaluation or Simpson-Angus scale evaluation(ESRS),Apathy Evaluation Scale(AES-C),State-Trait Anxiety Inventory(STAI),Beck Depression Inventory(BDI-13),Eysenck Personality Questionnaire-Revised(EPQ-R),Assessment of Schizotypal Personality(SPQ),Emotion Regulation Questionnaire(ERQ),Emotional Reactivity Scale(ERS),Toronto Alexithymia Scale(TAS-20),social anhedonia scale(SAS),Childhood Trauma Questionnaire(CTQ),Clinical-administered Post Traumatic Stress Disorder Scale(CAPS),Wechsler Adult Intelligence Scale(WAIS-III),Trail Making Test(TMT),Pen and paper visuospatial working memory(DOT-test),impulsivity test(GoStop),Stroop test,National Adult Reading Test(NART),Wechsler Adult Intelligence Scale(WAIS-III),Facial Emotion Recognition task(FER)
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenic patients | Patients will have clinical psychiatric evaluation, brain imaging and blood sample Receives: Device: magnetic resonance imaging (MRI); Procedure: Blood sample; Other: Clinical psychiatric evaluation | |
| Related volunteers (first degree relative of patient) | Related volunteers will have clinical psychiatric evaluation, brain imaging and blood sample Receives: Device: magnetic resonance imaging (MRI); Procedure: Blood sample; Other: Clinical psychiatric evaluation | |
| Healthy volunteers | Healthy volunteers will have clinical psychiatric evaluation, brain imaging and blood sample Receives: Device: magnetic resonance imaging (MRI); Procedure: Blood sample; Other: Clinical psychiatric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Trauma Questionnaire (CTQ) for childhood trauma.
development of an etiopathogenic model characteristic of schizophrenia
Childhood Trauma Questionnaire : to assess five types of childhood trauma :
- Emotional neglect
- physical abuse
- emotional abuse
- physical neglect
- sexual abuse
Each item being rated in 5 answer choice from 1 to 5 (never, rarely, sometimes, often or very often)
Measured: 5 days
Quantitative measurement of RNAs
development of an etiopathogenic model characteristic of schizophrenia
Measured: 5 days
Voxel-based morphometry (VBM) for total gray matter
development of an etiopathogenic model characteristic of schizophrenia
Measured: 5 days
Voxel-based morphometry (VBM) for regional gray matter density.
development of an etiopathogenic model characteristic of schizophrenia
Measured: 5 days
Secondary outcomes (6)
Connectivity in the cortico-limbic circuit
Measured: 5 days
Volumetry of the brain
Measured: 5 days
Correlation of BOLD activity in the cortico-limbic circuit in patients with patients with symptomatic variables
symptomatic variables : PANSS scale
Measured: 5 days
Correlation of BOLD activity in the cortico-limbic circuit with emotional variables
emotional variables : ERS scale, ERQ scale, TAS-20 scale, SAS scale, AES-C scale
Measured: 5 days
Correlation of BOLD activity in the cortico-limbic circuit with personality characteristics
personality characteristics : EPQ-R scale, SPQ scale
Measured: 5 days
Correlation of BOLD activity in the cortico-limbic circuit with history of trauma in childhood
history of trauma in childhood : CTQ scale
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start14 Nov 2018
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355781
- Sponsor's protocol ID
- 1608039
- Other IDs
- 2017-A00408-45
- Acronym
- SCHIZO'TRAUMA
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2017
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology. SCHIZO' TRAUMA
- ClinicalTrials.gov ID
- NCT03355781
- Acronym / sponsor ID
- SCHIZO'TRAUMA / 1608039
- Conditions
- Schizophrenia
- Keywords
- childhood trauma, candidate gene expression, cerebral morphology, schizophrenic symptomatology, conceptual framework of stress vulnerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 28 Nov 2017 (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.
Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers, these adversities are linked to a decrease of grey matter of the brain, similar to those observed in schizophrenia.
In a previous study based on Voxel-Based Morphometry (VBM), including 21 schizophrenic patients and 30 healthy volunteers, the investigators shown a negative correlation between emotional neglect (important dimension in childhood trauma) and grey matter decrease. This strong correlation was significantly higher in schizophrenic patients than in healthy volunteers, suggesting a higher genetic predisposition to environmental factors in schizophrenic people.
Currently, interaction between genetic predisposition and environmental stress factors is the major model for understanding in schizophrenia. In order to analyze both effects on human body, particularly on brain, several studies currently focus on the product of genetic expression, the ribonucleic acid (ARN).
The purpose of this study is to provide an explanatory model of links between childhood trauma, candidate gene for schizophrenia expression, cerebral morphology and schizophrenic symptomatology. Using conceptual framework of stress vulnerability, structural equation modeling (SEM) will allow testing causal link between these different variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schizophrenic patients | – | Device: magnetic resonance imaging (MRI), Procedure: Blood sample, Other: Clinical psychiatric evaluationPatients will have clinical psychiatric evaluation, brain imaging and blood sample |
| Related volunteers (first degree relative of patient) | – | Device: magnetic resonance imaging (MRI), Procedure: Blood sample, Other: Clinical psychiatric evaluationRelated volunteers will have clinical psychiatric evaluation, brain imaging and blood sample |
| Healthy volunteers | – | Device: magnetic resonance imaging (MRI), Procedure: Blood sample, Other: Clinical psychiatric evaluationHealthy volunteers will have clinical psychiatric evaluation, brain imaging and blood sample |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Schizophrenic patients, related volunteers (first degree relative of patient) and healthy volunteers
Key inclusion criteria (23 listed)
- For women with reproductively active age period: suitable contraceptive method and negative pregnancy test
- Schizophrenia diagnosis (according to DSM 5)
- Regular follow-up care at hospital
- No change in antipsychotic medication (medication AND dosage) within at least six weeks
- Patient into remission : constant dosage, out-patient and meeting Andreassen criteria
Key exclusion criteria (18 listed)
- For women with reproductively active age period: no suitable contraceptive method (oral, hormonal, intramuscular, intrauterine device, or surgical)
- Pregnancy or breastfeeding
- Not meeting schizophrenic criteria according to DSM 5 or presenting resistant schizophrenic criteria according Kane criteria
- Presenting a serious somatic disorder or neurological (particularly Parkinson disease, epilepsy, tardive dyskinesia)
- Cardiovascular, hepatic or serious renal diseases
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 |
|---|---|---|
| magnetic resonance imaging (MRI)brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity | Device | Healthy volunteers, Related volunteers (first degree relative of patient), Schizophrenic patients |
| Blood sample27,5 ml of blood sample : genetic analysis and biobank | Procedure or surgery | Healthy volunteers, Related volunteers (first degree relative of patient), Schizophrenic patients |
| Clinical psychiatric evaluationGlobal Assessment Scale(GAS),Mini International Neuropsychiatric Interview(MINI),Positive and Negative Symptoms Scale(PANSS),Family Interview for Genetic Studies(FIGS),Calgary Depression Scale for Schizophrenia(CDSS),extrapyramidal side effects evaluation or Simpson-Angus scale evaluation(ESRS),Apathy Evaluation Scale(AES-C),State-Trait Anxiety Inventory(STAI),Beck Depression Inventory(BDI-13),Eysenck Personality Questionnaire-Revised(EPQ-R),Assessment of Schizotypal Personality(SPQ),Emotion Regulation Questionnaire(ERQ),Emotional Reactivity Scale(ERS),Toronto Alexithymia Scale(TAS-20),social anhedonia scale(SAS),Childhood Trauma Questionnaire(CTQ),Clinical-administered Post Traumatic Stress Disorder Scale(CAPS),Wechsler Adult Intelligence Scale(WAIS-III),Trail Making Test(TMT),Pen and paper visuospatial working memory(DOT-test),impulsivity test(GoStop),Stroop test,National Adult Reading Test(NART),Wechsler Adult Intelligence Scale(WAIS-III),Facial Emotion Recognition task(FER) | Other | Healthy volunteers, Related volunteers (first degree relative of patient), Schizophrenic patients |
Primary outcome
Childhood Trauma Questionnaire (CTQ) for childhood trauma.
Time frame: 5 days
development of an etiopathogenic model characteristic of schizophrenia Childhood Trauma Questionnaire : to assess five types of childhood trauma : 1. Emotional neglect 2. physical abuse 3. emotional abuse 4. physical neglect 5. sexual abuse Each item being rated in 5 answer choice from 1 to 5 (never, rarely, sometimes, often or very often)
Quantitative measurement of RNAs
Time frame: 5 days
development of an etiopathogenic model characteristic of schizophrenia
Voxel-based morphometry (VBM) for total gray matter
Time frame: 5 days
development of an etiopathogenic model characteristic of schizophrenia
Voxel-based morphometry (VBM) for regional gray matter density.
Time frame: 5 days
development of an etiopathogenic model characteristic of schizophrenia
6 secondary outcomes
Connectivity in the cortico-limbic circuit
Time frame: 5 days
Volumetry of the brain
Time frame: 5 days
Correlation of BOLD activity in the cortico-limbic circuit in patients with patients with symptomatic variables
Time frame: 5 days
Correlation of BOLD activity in the cortico-limbic circuit with emotional variables
Time frame: 5 days
Correlation of BOLD activity in the cortico-limbic circuit with personality characteristics
Time frame: 5 days
Correlation of BOLD activity in the cortico-limbic circuit with history of trauma in childhood
Time frame: 5 days
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 17 Jan 2024.
- 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, run by Centre Hospitalier Universitaire de Saint Etienne 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 23 inclusion and 18 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 17 Jan 2024. 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?
Childhood Trauma Questionnaire (CTQ) for childhood trauma. (time frame: 5 days). The study lists 4 primary outcomes in all. 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 17 Jan 2024.