Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology
SCHIZO'TRAUMA
2 other identifiers
observational
78
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 28, 2017
CompletedStudy Start
First participant enrolled
November 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedJanuary 17, 2024
January 1, 2024
5 years
November 10, 2017
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 : 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)
5 days
Quantitative measurement of RNAs
development of an etiopathogenic model characteristic of schizophrenia
5 days
Voxel-based morphometry (VBM) for total gray matter
development of an etiopathogenic model characteristic of schizophrenia
5 days
Voxel-based morphometry (VBM) for regional gray matter density.
development of an etiopathogenic model characteristic of schizophrenia
5 days
Secondary Outcomes (6)
Connectivity in the cortico-limbic circuit
5 days
Volumetry of the brain
5 days
Correlation of BOLD activity in the cortico-limbic circuit in patients with patients with symptomatic variables
5 days
Correlation of BOLD activity in the cortico-limbic circuit with emotional variables
5 days
Correlation of BOLD activity in the cortico-limbic circuit with personality characteristics
5 days
- +1 more secondary outcomes
Study Arms (3)
Schizophrenic patients
Patients will have clinical psychiatric evaluation, brain imaging and blood sample
Related volunteers (first degree relative of patient)
Related volunteers will have clinical psychiatric evaluation, brain imaging and blood sample
Healthy volunteers
Healthy volunteers will have clinical psychiatric evaluation, brain imaging and blood sample
Interventions
brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity
27,5 ml of blood sample : genetic analysis and biobank
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)
Eligibility Criteria
Schizophrenic patients, related volunteers (first degree relative of patient) and healthy volunteers
You may qualify if:
- 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.
- Physical examination without significant clinical physical anomaly
- No serious somatic pathology
- Affiliates or entitled to a social security scheme
You may not qualify if:
- 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
- Claustrophobia, significant tatoo in the high part of the body, IUD incompatible with MRI 3Tesla
- Alcohol or drug addiction, within the last year
- Susceptibility to self-harm behaviour according to investigator
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Saint Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 28, 2017
Study Start
November 14, 2018
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
January 17, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share