Status:
COMPLETED
Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
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 schizo...
Eligibility Criteria
Inclusion
- 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
- Exclusion Criteria of Related volunteers :
- 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
- Inclusion Criteria of Healthy volunteers :
- 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 of Healthy volunteers :
- Beside the absence of schizophrenia diagnosis, healthy volunteers should meet the same exclusion criteria as patients
Exclusion
Key Trial Info
Start Date :
November 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03355781
Start Date
November 14 2018
End Date
November 30 2023
Last Update
January 17 2024
Active Locations (1)
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1
CHU de Saint Etienne
Saint-Etienne, France, 42055