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Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology

Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology. SCHIZO' TRAUMA

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03355781
Acronym
SCHIZO'TRAUMA
Enrollment
78
Registered
2017-11-28
Start date
2018-11-14
Completion date
2023-11-30
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

childhood trauma, candidate gene expression, cerebral morphology, schizophrenic symptomatology, conceptual framework of stress vulnerability

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.

Interventions

DEVICEmagnetic resonance imaging (MRI)

brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity

PROCEDUREBlood sample

27,5 ml of blood sample : genetic analysis and biobank

OTHERClinical psychiatric evaluation

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)

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

of patients : * 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

Exclusion criteria

of patients : * 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 * Recruited in other clinical trial or exclusion period from previous trial. * Susceptibility to self-harm behaviour according to investigator Inclusion Criteria of Related volunteers : * 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

Design outcomes

Primary

MeasureTime frameDescription
Childhood Trauma Questionnaire (CTQ) for childhood trauma.5 daysdevelopment 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 RNAs5 daysdevelopment of an etiopathogenic model characteristic of schizophrenia
Voxel-based morphometry (VBM) for total gray matter5 daysdevelopment of an etiopathogenic model characteristic of schizophrenia
Voxel-based morphometry (VBM) for regional gray matter density.5 daysdevelopment of an etiopathogenic model characteristic of schizophrenia

Secondary

MeasureTime frameDescription
Correlation of BOLD activity in the cortico-limbic circuit with personality characteristics5 dayspersonality characteristics : EPQ-R scale, SPQ scale
Connectivity in the cortico-limbic circuit5 days
Correlation of BOLD activity in the cortico-limbic circuit with history of trauma in childhood5 dayshistory of trauma in childhood : CTQ scale
Volumetry of the brain5 days
Correlation of BOLD activity in the cortico-limbic circuit in patients with patients with symptomatic variables5 dayssymptomatic variables : PANSS scale
Correlation of BOLD activity in the cortico-limbic circuit with emotional variables5 daysemotional variables : ERS scale, ERQ scale, TAS-20 scale, SAS scale, AES-C scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026