Trial record 2 of 6 for:
Open Studies | "Fetal Development"
Schizophrenia Imaging
This study is not yet open for participant recruitment.
Verified July 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Tel-Aviv Sourasky Medical Center
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
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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:
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:
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
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. | IDF |
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 May 22, 2013