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
  Purpose

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.


Condition Intervention
Foetal Differences Between Healthy and Schizophernic Parents
Device: imaging follow up: MRI scan
Device: imaging follow up: Ultrasonographic examination

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Prospective Ultrasonographic and Magnetic Resonance Imaging (MRI) Assessment of General and Brain Fetal Development in Offspring of Schizophrenic Patients

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 .


Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: healthy 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: schizophrenic 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655472

Contacts
Contact: Nivi Rotenberg, M.D 972-50-7744593 nivirot@gmail.com
Contact: Miki Bloch, M.D. mikib@tlvmc.gov.il

Locations
Israel
Abarbanel Mental Health Centre Not yet recruiting
Bat Yam, Israel
Contact: Ido Lurie, M.D.         
Beer Yaacov Mental health Centre Not yet recruiting
Beer Yaakov, Israel
Contact: Faina Bar, M.D.         
Shalvata mental health centre
Hod Hasharon, Israel
Edith Wolfson Medical Centre Not yet recruiting
Holon, Israel
Contact: Gustavo Malinger, M.D.         
Geha mental health centre Not yet recruiting
Petah Tiqwa, Israel
Contact: Avi Weizman, Proffesor         
Sourasky Medical Centre Not yet recruiting
Tel Aviv, Israel
Contact: Miki Bloch, M.D.         
Brill outpatient clinic Not yet recruiting
Tel Aviv, Israel
Contact: Nitsa Nakash, M.D.         
Chaim Sheba medical centre Not yet recruiting
Tel Hashomer, Israel
Contact: Judith Reidman, M.D.         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nivi Rotenberg, M.D. International Diabetes Federation
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01655472     History of Changes
Other Study ID Numbers: TASMC-11-NR-0192-11-CTIL, 18105
Study First Received: June 30, 2012
Last Updated: July 31, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
schizophrenia
imaging

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014