Schizophrenia Imaging

NCT ID: NCT01655472

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-07-31

Brief Summary

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Schizophrenia is a common disorder with a lifetime prevalence of about 1%.Genetic studies strongly suggest a genetic component to the inheritance of schizophrenia. Structural neuroimaging studies have provided consistent evidence for brain abnormalities in schizophrenia. The timing of brain abnormalities in schizophrenia has not been determined yet.

The investigators hypothesize that brain structural changes can be detected in neonatal life. The investigators hypothesize that offspring of schizophrenic patients will have higher rates of brain structural changes in the neonatal period. The investigators propose to study early development of fetuses in offspring of patients with schizophrenia. The study is a multi-center prospective trial.

Detailed Description

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Conditions

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Foetal Differences Between Healthy and Schizophernic Parents

Keywords

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schizophrenia imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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healthy parents

Group Type ACTIVE_COMPARATOR

imaging follow up: MRI scan

Intervention Type DEVICE

.1 Psychiatric interview. 2. Questionnaires 3. Blood samples for triple test: alfa feto protein, HCG, E3 4. A thorough fetal ultrasound examination including anatomic screening on 23-24 weeks of pregnancy. 5. A detailed trans-vaginal neurosonographic multi-planer examination, on 32-34 weeks of pregnancy 6. Fetal MRI scan on 32-34 weeks of pregnancy, 7. Newborn brain transfontanelar ultrasonography ,within 2 months postpartum 8. Newborn medical examination within 2 months postpartum.

imaging follow up: Ultrasonographic examination

Intervention Type DEVICE

schizophrenic parents

Group Type ACTIVE_COMPARATOR

imaging follow up: MRI scan

Intervention Type DEVICE

.1 Psychiatric interview. 2. Questionnaires 3. Blood samples for triple test: alfa feto protein, HCG, E3 4. A thorough fetal ultrasound examination including anatomic screening on 23-24 weeks of pregnancy. 5. A detailed trans-vaginal neurosonographic multi-planer examination, on 32-34 weeks of pregnancy 6. Fetal MRI scan on 32-34 weeks of pregnancy, 7. Newborn brain transfontanelar ultrasonography ,within 2 months postpartum 8. Newborn medical examination within 2 months postpartum.

imaging follow up: Ultrasonographic examination

Intervention Type DEVICE

Interventions

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imaging follow up: MRI scan

.1 Psychiatric interview. 2. Questionnaires 3. Blood samples for triple test: alfa feto protein, HCG, E3 4. A thorough fetal ultrasound examination including anatomic screening on 23-24 weeks of pregnancy. 5. A detailed trans-vaginal neurosonographic multi-planer examination, on 32-34 weeks of pregnancy 6. Fetal MRI scan on 32-34 weeks of pregnancy, 7. Newborn brain transfontanelar ultrasonography ,within 2 months postpartum 8. Newborn medical examination within 2 months postpartum.

Intervention Type DEVICE

imaging follow up: Ultrasonographic examination

Intervention Type DEVICE

Other Intervention Names

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1. MRI 1.5 T & 3.0 T, MR systems, GE 1.5 & 3T Signa HDx MR system, General Electric Medical Technologies 2. GE MEDICAL SYSTEMS, ULTRASOUND, GE Medical Systems Kretztechnik GmBH & Co OHG

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who carry an offspring of a schizophrenia patient: whether the mother, the father or both suffer from schizophrenia.

Exclusion Criteria

* Alcohol or drug abuse of pregnant woman
* Past history or present occurrence of major neurologic or somatic illness
* Genetic disease
* Other psychiatric disorders other than schizophrenia such as Mental retardation
* Bipolar Disorder and Delusional Disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nivi Rotenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Federation

Locations

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Abarbanel Mental Health Centre

Bat Yam, , Israel

Site Status

Beer Yaacov Mental health Centre

Beer Yaakov, , Israel

Site Status

Shalvata mental health centre

Hod HaSharon, , Israel

Site Status

Edith Wolfson Medical Centre

Holon, , Israel

Site Status

Geha mental health centre

Petah Tikva, , Israel

Site Status

Brill outpatient clinic

Tel Aviv, , Israel

Site Status

Sourasky Medical Centre

Tel Aviv, , Israel

Site Status

Chaim Sheba medical centre

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nivi Rotenberg, M.D

Role: CONTACT

Phone: 972-50-7744593

Email: [email protected]

Miki Bloch, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ido Lurie, M.D.

Role: primary

Faina Bar, M.D.

Role: primary

Gustavo Malinger, M.D.

Role: primary

Avi Weizman, Proffesor

Role: primary

Nitsa Nakash, M.D.

Role: primary

Miki Bloch, M.D.

Role: primary

Judith Reidman, M.D.

Role: primary

Other Identifiers

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18105

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TASMC-11-NR-0192-11-CTIL

Identifier Type: -

Identifier Source: org_study_id