Evaluating Genetic Risk Factors for Childhood-Onset Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001198
First received: November 3, 1999
Last updated: June 26, 2014
Last verified: June 2014

November 3, 1999
June 26, 2014
March 1984
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Complete list of historical versions of study NCT00001198 on ClinicalTrials.gov Archive Site
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Evaluating Genetic Risk Factors for Childhood-Onset Schizophrenia
Biochemical, Physiological, and Psychological Measures in Normal Controls and Relatives of Psychiatric Patients

A study of children and adolescents (current N=100) 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 (10.4%) 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 1:7 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 delays/abnormalities 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 children and adolescents (current N = 117 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 case (1,2). The focus has now shifted to increasing the sample size and evaluation of familial risk factors including: psychiatric diagnoses of family members; neuropsychological test deficits, 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 show significant relationship to the developmental delays/abnormalities being observed in the COS probands.

Observational
Time Perspective: Prospective
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  • Psychosis
  • Schizophrenia
  • Genetic Structure
  • Childhood Onset Psychotic Disorders
  • Schizoaffective Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1975
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  • INCLUSION CRITERIA:

Inclusion criteria for healthy controls will continue to be:

  1. Ages 6 and above
  2. Evidence of normal developmental history and normal functioning.

Inclusion criteria for relatives of probands will be:

  1. Ages 6 and above
  2. Evidence of blood relationship to proband with a disorder under study, with usual selection of first-degree relatives, and occasional participation of more distantly-related relatives (grandparents, aunts/uncles and cousins).

EXCLUSION CRITERIA:

Exclusion criteria for community controls are:

  1. Evidence of medical or neurological disease.
  2. Diagnosis of schizophrenia or schizoaffective disorder in the control or in first degree relatives by history, clinical interview, or by structured, diagnostic psychiatric interview (Diagnostic Interview for Children and Adolescents IV).

Exclusion criteria for relatives of probands:

  1. Absence of consent on the part of the proband or parent(s) of proband to contact relatives
  2. Absence of signed consent or assent by relative(s) to participate
  3. Lack of consent capacity
Both
6 Years and older
Yes
Contact: Judith L Rapoport, M.D. (301) 435-4501 rapoporj@mail.nih.gov
United States
 
NCT00001198
840050, 84-M-0050
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National Institute of Mental Health (NIMH)
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Principal Investigator: Judith L Rapoport, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP