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.

Study Overview

• Status: Unknown
• Conditions: Foetal Differences Between Healthy and Schizophernic Parents
• Intervention / Treatment: Device: imaging follow up: MRI scan; Device: imaging follow up: Ultrasonographic examination

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bat Yam, Israel
    • Abarbanel Mental Health Centre
  • Beer Yaakov, Israel
    • Beer Yaacov Mental health Centre
  • Hod Hasharon, Israel
    • Shalvata mental health centre
  • Holon, Israel
    • Edith Wolfson Medical Centre
  • Petah Tiqwa, Israel
    • Geha mental health centre
  • Tel Aviv, Israel
    • Brill outpatient clinic
  • Tel Aviv, Israel
    • Sourasky Medical Centre
  • Tel Hashomer, Israel
    • Chaim Sheba Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain morphological changes between groups	Both MRI scans and US scans will be compared between the groups, assessing brain morphological and volumetric differences .	2 years

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Nivi Rotenberg, M.D., International Diabetes Federation

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: June 30, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: imaging; schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: TASMC-11-NR-0192-11-CTIL; 18105 (2010 NARSAD Young Investigator Award)