Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001198
Status:
TERMINATED
Last Update Posted:
2017-10-12
First Post:
1999-11-03
Brief Title:
Evaluating Genetic Risk Factors for Childhood-Onset Schizophrenia
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biochemical Physiological and Psychological Measures in Normal Controls and Relatives of Psychiatric Patients
Status:
TERMINATED
Status Verified Date:
2017-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study of children and adolescents current N100 with very early onset by age 12 COS of DSM-III-R defined schizophrenia with 97-M-0126 is examining the clinical neurobiological early neurodevelopmental genetic and clinical drug response characteristics of these cases Earlier studies have documented the continuity between COS and adult onset cases See Jacobsen and Rapoport 1998 for review The focus has now shifted to increasing the sample size and evaluation of familial risk factors including psychiatric diagnoses of family members smooth pursuit eye movements neuropsychological tests deficits and obtaining blood for cell lines for genetic studies family members only this is also covered under 96-M-0060 Dr Ellen Sidransky
A study of obstetrical records of COS probands indicated no increase in adverse pre or perinatal events for these cases compared with obstetrical records of their siblings Nicolson et al submitted In contrast several findings point to increased risk for these probands To date a total of 5 104 COS subjects were found to have previously unknown cytogenetic abnormalities Microdeletion of 22q11 3 cases Usiskin et al submitted Mosaic 45X0 one case Kumra et al 1998 and balanced 17 translocation Gordon et al 1994
The study of first degree relatives of these very rare cases addresses the hypothesis that risk factors most probably genetic are increased in immediate family members relative both to community controls and to the relatives of patients with chronic treatment resistant adult-onset schizophrenia AOS A second hypothesis is that COS familial risk factors show significant relationship to the developmental delaysabnormalities being observed in the COS probands As a total of 50 additional COS subjects will be studied over the next 5 years the pediatric control sample for the probands will also be increased determined by the need to have concurrent measures for patients and controls to maintain measurement validity Thus a total of 600 additional subjects are to be studied including 50 controls for COS probands 150 COS relatives 150 controls for COS relatives and 250 relatives of adult onset schizophrenics AOS
A study of obstetrical records of COS probands indicated no increase in adverse pre or perinatal events for these cases compared with obstetrical records of their siblings Nicolson et al submitted In contrast several findings point to increased risk for these probands To date a total of 5 104 COS subjects were found to have previously unknown cytogenetic abnormalities Microdeletion of 22q11 3 cases Usiskin et al submitted Mosaic 45X0 one case Kumra et al 1998 and balanced 17 translocation Gordon et al 1994
The study of first degree relatives of these very rare cases addresses the hypothesis that risk factors most probably genetic are increased in immediate family members relative both to community controls and to the relatives of patients with chronic treatment resistant adult-onset schizophrenia AOS A second hypothesis is that COS familial risk factors show significant relationship to the developmental delaysabnormalities being observed in the COS probands As a total of 50 additional COS subjects will be studied over the next 5 years the pediatric control sample for the probands will also be increased determined by the need to have concurrent measures for patients and controls to maintain measurement validity Thus a total of 600 additional subjects are to be studied including 50 controls for COS probands 150 COS relatives 150 controls for COS relatives and 250 relatives of adult onset schizophrenics AOS
Detailed Description:
A study of children and adolescents with very early onset by age 12 COS of DSM-III-R defined schizophrenia is examining the clinical neurobiological early neurodevelopmental genetic and clinical drug response characteristics of these cases under Protocols 97-M-0126 and 03-M-0035 Earlier studies have documented the continuity between COS and adult-onset cases The focus has now shifted to increasing the sample size and evaluation of familial risk factors including psychiatric diagnoses of family members neuropsychological testing anatomic and functional brain imaging and obtaining blood and fibroblasts for cell lines for genetic studies
A study of obstetrical records of COS probands indicated no increase in adverse pre or perinatal events for these cases compared with obstetrical records of their well siblings In contrast several findings point to increased genetic risk for these probands
The study of first-degree relatives of these very rare cases addresses the hypothesis that risk factors most probably genetic are increased in immediate family members relative both to community controls and to the relatives of patients with chronic treatment resistant adult-onset schizophrenia AOS A second hypothesis is that COS familial risk factors include similar forms of the developmental delaysabnormalities being observed in the COS probands Preliminary data suggests greater abnormalities of frontal-parietal circuits for early onset patients and their relatives than seen in adult onset illness
We will examine brain development in unrelated healthy volunteers and siblings of our COS probands by combining resting- and task-related magnetic resonance imaging MRI and magnetoencephalography MEG imaging Imaging studies may lead to greater understanding of the course mechanisms and influences on brain development of high-risk siblings and may lead to improved understanding of the risk factors early identification and optimization of brain maturation For more than 20 years imaging has been done under a separate protocol 89-M-0006 however we now plan to incorporate these imaging studies into this protocol as well as into our main patient screening and follow-up protocol 03-M-0035 by previously submitted amendment
A study of obstetrical records of COS probands indicated no increase in adverse pre or perinatal events for these cases compared with obstetrical records of their well siblings In contrast several findings point to increased genetic risk for these probands
The study of first-degree relatives of these very rare cases addresses the hypothesis that risk factors most probably genetic are increased in immediate family members relative both to community controls and to the relatives of patients with chronic treatment resistant adult-onset schizophrenia AOS A second hypothesis is that COS familial risk factors include similar forms of the developmental delaysabnormalities being observed in the COS probands Preliminary data suggests greater abnormalities of frontal-parietal circuits for early onset patients and their relatives than seen in adult onset illness
We will examine brain development in unrelated healthy volunteers and siblings of our COS probands by combining resting- and task-related magnetic resonance imaging MRI and magnetoencephalography MEG imaging Imaging studies may lead to greater understanding of the course mechanisms and influences on brain development of high-risk siblings and may lead to improved understanding of the risk factors early identification and optimization of brain maturation For more than 20 years imaging has been done under a separate protocol 89-M-0006 however we now plan to incorporate these imaging studies into this protocol as well as into our main patient screening and follow-up protocol 03-M-0035 by previously submitted amendment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 84-M-0050 | None | None | None |