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Schizophrenia Imaging

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01655472
First received: June 30, 2012
Last updated: July 31, 2012
Last verified: July 2012

June 30, 2012
July 31, 2012
July 2012
July 2014   (final data collection date for primary outcome measure)
Brain morphological changes between groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Both MRI scans and US scans will be compared between the groups, assessing brain morphological and volumetric differences .
Same as current
Complete list of historical versions of study NCT01655472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Schizophrenia Imaging
Prospective Ultrasonographic and Magnetic Resonance Imaging (MRI) Assessment of General and Brain Fetal Development in Offspring of Schizophrenic Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Foetal Differences Between Healthy and Schizophernic Parents
  • Device: 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.
    Other Names:
    • 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
  • Device: imaging follow up: Ultrasonographic examination
  • Active Comparator: healthy parents
    Interventions:
    • Device: imaging follow up: MRI scan
    • Device: imaging follow up: Ultrasonographic examination
  • Active Comparator: schizophrenic parents
    Interventions:
    • Device: imaging follow up: MRI scan
    • Device: imaging follow up: Ultrasonographic examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
July 2015
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
Yes
Contact: Nivi Rotenberg, M.D 972-50-7744593 nivirot@gmail.com
Contact: Miki Bloch, M.D. mikib@tlvmc.gov.il
Israel
 
NCT01655472
TASMC-11-NR-0192-11-CTIL, 18105
No
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Nivi Rotenberg, M.D. International Diabetes Federation
Tel-Aviv Sourasky Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP