Schizophrenia Imaging

Foetal Differences Between Healthy and Schizophernic Parents Clinical Trial

Official title:

Prospective Ultrasonographic and Magnetic Resonance Imaging (MRI) Assessment of General and Brain Fetal Development in Offspring of Schizophrenic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01655472
• Other study ID #: TASMC-11-NR-0192-11-CTIL
• Secondary ID: 18105
• Status: Not yet recruiting
• Phase: N/A
• First received: June 30, 2012
• Last updated: July 31, 2012
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nivi Rotenberg, M.D
• Phone: 972-50-7744593
• Email: nivirot[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Foetal Differences Between Healthy and Schizophernic Parents

Intervention

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.
• imaging follow up: Ultrasonographic examination

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No