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

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ClinicalTrials.gov Identifier: NCT03355781
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Schizophrenia Device: magnetic resonance imaging (MRI) Procedure: Blood sample Other: Clinical psychiatric evaluation

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology. SCHIZO' TRAUMA
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Schizophrenic patients
Patients will have clinical psychiatric evaluation, brain imaging and blood sample
Device: magnetic resonance imaging (MRI)
brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity

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

Other: 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)

Related volunteers (first degree relative of patient)
Related volunteers will have clinical psychiatric evaluation, brain imaging and blood sample
Device: magnetic resonance imaging (MRI)
brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity

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

Other: 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)

Healthy volunteers
Healthy volunteers will have clinical psychiatric evaluation, brain imaging and blood sample
Device: magnetic resonance imaging (MRI)
brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity

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

Other: 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)




Primary Outcome Measures :
  1. 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)


  2. Quantitative measurement of RNAs [ Time Frame: 5 days ]
    development of an etiopathogenic model characteristic of schizophrenia

  3. Voxel-based morphometry (VBM) for total gray matter [ Time Frame: 5 days ]
    development of an etiopathogenic model characteristic of schizophrenia

  4. Voxel-based morphometry (VBM) for regional gray matter density. [ Time Frame: 5 days ]
    development of an etiopathogenic model characteristic of schizophrenia


Secondary Outcome Measures :
  1. Connectivity in the cortico-limbic circuit [ Time Frame: 5 days ]
  2. Volumetry of the brain [ Time Frame: 5 days ]
  3. Correlation of BOLD activity in the cortico-limbic circuit in patients with patients with symptomatic variables [ Time Frame: 5 days ]
    symptomatic variables : PANSS scale

  4. Correlation of BOLD activity in the cortico-limbic circuit with emotional variables [ Time Frame: 5 days ]
    emotional variables : ERS scale, ERQ scale, TAS-20 scale, SAS scale, AES-C scale

  5. Correlation of BOLD activity in the cortico-limbic circuit with personality characteristics [ Time Frame: 5 days ]
    personality characteristics : EPQ-R scale, SPQ scale

  6. Correlation of BOLD activity in the cortico-limbic circuit with history of trauma in childhood [ Time Frame: 5 days ]
    history of trauma in childhood : CTQ scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Schizophrenic patients, related volunteers (first degree relative of patient) and healthy volunteers
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355781


Contacts
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Contact: Samy DALLEL, MD 0477828720 ext +33 samy.dallel@chu-st-etienne.fr
Contact: Marie PEURIERE (0)477829272 ext 33 marie.peuriere@chu-st-etienne.fr

Locations
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France
CHU de Saint Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Samy DALLEL, MD    0477828720 ext +33    samy.dallel@chu-st-etienne.fr   
Sub-Investigator: Eric FAKRA, MD PhD         
Sub-Investigator: Claire BOUTET, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03355781     History of Changes
Other Study ID Numbers: 1608039
2017-A00408-45 ( Other Identifier: ANSM )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
childhood trauma
candidate gene expression
cerebral morphology
schizophrenic symptomatology
conceptual framework of stress vulnerability

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders