Foetal Differences Between Healthy and Schizophernic ParentsNCT01655472
Schizophrenia Imaging
A study testing imaging follow up: MRI scan and imaging follow up: Ultrasonographic examination in people with Foetal Differences Between Healthy and Schizophernic Parents, run by Tel-Aviv Sourasky Medical Center at 8 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Foetal Differences Between Healthy and Schizophernic Parents
- What is being tested?
- imaging follow up: MRI scan and imaging follow up: Ultrasonographic examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesIsrael
- Study dates
- Jul 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who carry an offspring of a schizophrenia patient: whether the mother, the father or both suffer from schizophrenia.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
Miki Bloch, M.D. contact
8 sites in 1 country
Israel8 sites
Abarbanel Mental Health Centre
Bat Yam
Ido Lurie, M.D.
Beer Yaacov Mental health Centre
Beer Yaakov
Faina Bar, M.D.
Shalvata mental health centre
Hod HaSharon
Edith Wolfson Medical Centre
Holon
Gustavo Malinger, M.D.
Geha mental health centre
Petah Tikva
Avi Weizman, Proffesor
Brill outpatient clinic
Tel Aviv
Nitsa Nakash, M.D.
Sourasky Medical Centre
Tel Aviv
Miki Bloch, M.D.
Chaim Sheba medical centre
Tel HaShomer
Judith Reidman, M.D.
About this study
Official title: 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.
- Being tested
- imaging follow up: MRI scan, imaging follow up: Ultrasonographic examination
- Keywords
- schizophrenia, imaging
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging follow up: MRI scanDevice
Also called 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
.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 examinationDevice
| Study group | Role | What they receive |
|---|---|---|
| healthy parents | Active comparator | Not described Receives: Device: imaging follow up: MRI scan; Device: imaging follow up: Ultrasonographic examination |
| schizophrenic parents | Active comparator | Not described Receives: Device: imaging follow up: MRI scan; Device: imaging follow up: Ultrasonographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain morphological changes between groups
Both MRI scans and US scans will be compared between the groups, assessing brain morphological and volumetric differences .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foetal Differences Between Healthy and Schizophernic ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nivi Rotenberg, M.D., Principal investigator, International Diabetes Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655472
- Sponsor's protocol ID
- TASMC-11-NR-0192-11-CTIL
- Other IDs
- 18105
- Status last verified
- Jul 2012
- First submitted
- 30 Jun 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Ultrasonographic and Magnetic Resonance Imaging (MRI) Assessment of General and Brain Fetal Development in Offspring of Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT01655472
- Acronym / sponsor ID
- TASMC-11-NR-0192-11-CTIL
- Keywords
- schizophrenia, imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy parents | Active comparator | Device: imaging follow up: MRI scan, Device: imaging follow up: Ultrasonographic examination |
| schizophrenic parents | Active comparator | Device: imaging follow up: MRI scan, Device: imaging follow up: Ultrasonographic examination |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women who carry an offspring of a schizophrenia patient: whether the mother, the father or both suffer from schizophrenia.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaging follow up: MRI scanAlso: 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.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. | Device | healthy parents, schizophrenic parents |
| imaging follow up: Ultrasonographic examination | Device | healthy parents, schizophrenic parents |
Primary outcome
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miki Bloch, M.D. contact
Nivi Rotenberg, M.D. principal investigator
International Diabetes Federation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaging follow up: MRI scan and imaging follow up: Ultrasonographic examination in people with Foetal Differences Between Healthy and Schizophernic Parents, run by Tel-Aviv Sourasky Medical Center at 8 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nivi Rotenberg, M.D (972-50-7744593, nivirot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain morphological changes between groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.