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

NCT ID: NCT03355781

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-14
• Study Completion Date: 2023-11-30

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.

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Schizophrenic patients

Patients will have clinical psychiatric evaluation, brain imaging and blood sample

magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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

Blood sample

Intervention Type: PROCEDURE

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

Clinical psychiatric evaluation

Intervention Type: OTHER

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)

Related volunteers (first degree relative of patient)

Related volunteers will have clinical psychiatric evaluation, brain imaging and blood sample

magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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

Blood sample

Intervention Type: PROCEDURE

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

Clinical psychiatric evaluation

Intervention Type: OTHER

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)

Healthy volunteers

Healthy volunteers will have clinical psychiatric evaluation, brain imaging and blood sample

magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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

Blood sample

Intervention Type: PROCEDURE

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

Clinical psychiatric evaluation

Intervention Type: OTHER

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)

Interventions

magnetic resonance imaging (MRI)

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

Intervention Type: DEVICE

Blood sample

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

Intervention Type: PROCEDURE

Clinical 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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2017-A00408-45

Identifier Type: OTHER

Identifier Source: secondary_id

1608039

Identifier Type: -

Identifier Source: org_study_id