NCT00001198

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1984

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 1984

Completed
15.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
17.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 10, 2017

First QC Date

November 3, 1999

Last Update Submit

October 11, 2017

Conditions

Keywords

SchizophreniaObservational

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • i. For Healthy Controls
  • Age 6 and above
  • Evidence of normal developmental history and normal functioning
  • ii. For Relatives of Probands
  • Ages 6 and above
  • 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 (e.g., grandparents, aunts/uncles, cousins).

You may not qualify if:

  • i.For Healthy Controls
  • Evidence of medical or neurological disease
  • Diagnosis of schizophrenia or schizoaffective disorder or in first-degree relatives by history, clinical interview, or by structured, diagnostic psychiatric interview (Diagnostic Interview for Children and Adolescents -IV)
  • ii.For Relatives of Probands
  • Absence of consent on the part of the proband or parent(s) of proband to contact relatives
  • Absence of signed consent or assent by relative(s) to participate
  • Lack of consent capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • Casey BJ, Castellanos FX, Giedd JN, Marsh WL, Hamburger SD, Schubert AB, Vauss YC, Vaituzis AC, Dickstein DP, Sarfatti SE, Rapoport JL. Implication of right frontostriatal circuitry in response inhibition and attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):374-83. doi: 10.1097/00004583-199703000-00016.

    PMID: 9055518BACKGROUND
  • Frazier JA, Alaghband-Rad J, Jacobsen L, Lenane MC, Hamburger S, Albus K, Smith A, McKenna K, Rapoport JL. Pubertal development and onset of psychosis in childhood onset schizophrenia. Psychiatry Res. 1997 Apr 18;70(1):1-7. doi: 10.1016/s0165-1781(97)03062-x.

    PMID: 9172272BACKGROUND
  • Zahn TP, Jacobsen LK, Gordon CT, McKenna K, Frazier JA, Rapoport JL. Autonomic nervous system markers of psychopathology in childhood-onset schizophrenia. Arch Gen Psychiatry. 1997 Oct;54(10):904-12. doi: 10.1001/archpsyc.1997.01830220020003.

    PMID: 9337769BACKGROUND
  • Loeb FF, Zhou X, Craddock KES, Shora L, Broadnax DD, Gochman P, Clasen LS, Lalonde FM, Berman RA, Berman KF, Rapoport JL, Liu S. Reduced Functional Brain Activation and Connectivity During a Working Memory Task in Childhood-Onset Schizophrenia. J Am Acad Child Adolesc Psychiatry. 2018 Mar;57(3):166-174. doi: 10.1016/j.jaac.2017.12.009. Epub 2017 Dec 28.

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Judith L Rapoport, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 19, 1984

Study Completion

October 10, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10-10

Locations