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Clinical Trials/NCT01655472
NCT01655472UnknownNot Applicable

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

Tel-Aviv Sourasky Medical Center8 sites in 1 country80 target enrollmentStarted: July 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Locations
8
Primary Endpoint
Brain morphological changes between groups

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

schizophrenic parents

Active Comparator

Intervention: imaging follow up: Ultrasonographic examination (Device)

healthy parents

Active Comparator

Intervention: imaging follow up: MRI scan (Device)

healthy parents

Active Comparator

Intervention: imaging follow up: Ultrasonographic examination (Device)

schizophrenic parents

Active Comparator

Intervention: imaging follow up: MRI scan (Device)

Outcomes

Primary Outcomes

Brain morphological changes between groups

Time Frame: 2 years

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (8)

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