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Schizophrenia Imaging

Primary Purpose

Foetal Differences Between Healthy and Schizophernic Parents

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
imaging follow up: MRI scan
imaging follow up: Ultrasonographic examination
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Foetal Differences Between Healthy and Schizophernic Parents focused on measuring schizophrenia, imaging

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Abarbanel Mental Health Centre
  • Beer Yaacov Mental health Centre
  • Shalvata mental health centre
  • Edith Wolfson Medical Centre
  • Geha mental health centre
  • Brill outpatient clinic
  • Sourasky Medical Centre
  • Chaim Sheba medical centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

healthy parents

schizophrenic parents

Arm Description

Outcomes

Primary Outcome Measures

Brain morphological changes between groups
Both MRI scans and US scans will be compared between the groups, assessing brain morphological and volumetric differences .

Secondary Outcome Measures

Full Information

First Posted
June 30, 2012
Last Updated
July 31, 2012
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01655472
Brief Title
Schizophrenia Imaging
Official Title
Prospective Ultrasonographic and Magnetic Resonance Imaging (MRI) Assessment of General and Brain Fetal Development in Offspring of Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foetal Differences Between Healthy and Schizophernic Parents
Keywords
schizophrenia, imaging

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy parents
Arm Type
Active Comparator
Arm Title
schizophrenic parents
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
imaging follow up: MRI scan
Other Intervention Name(s)
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
Intervention Description
.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
Intervention Name(s)
imaging follow up: Ultrasonographic examination
Primary Outcome Measure Information:
Title
Brain morphological changes between groups
Description
Both MRI scans and US scans will be compared between the groups, assessing brain morphological and volumetric differences .
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nivi Rotenberg, M.D
Phone
972-50-7744593
Email
nivirot@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Bloch, M.D.
Email
mikib@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nivi Rotenberg, M.D.
Organizational Affiliation
International Diabetes Federation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abarbanel Mental Health Centre
City
Bat Yam
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ido Lurie, M.D.
Facility Name
Beer Yaacov Mental health Centre
City
Beer Yaakov
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faina Bar, M.D.
Facility Name
Shalvata mental health centre
City
Hod Hasharon
Country
Israel
Facility Name
Edith Wolfson Medical Centre
City
Holon
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Malinger, M.D.
Facility Name
Geha mental health centre
City
Petah Tiqwa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi Weizman, Proffesor
Facility Name
Brill outpatient clinic
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitsa Nakash, M.D.
Facility Name
Sourasky Medical Centre
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miki Bloch, M.D.
Facility Name
Chaim Sheba medical centre
City
Tel Hashomer
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Reidman, M.D.

12. IPD Sharing Statement

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Schizophrenia Imaging

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