Terminated

Age: 6Years +
All Genders
Healthy Volunteers
ID00001198

Biochemical, Physiological, and Psychological Measures in Normal Controls and Relatives of Psychiatric Patients

Led by National Institute of Mental Health (NIMH) · Updated on 2017-10-12

1556

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Evaluating Genetic Risk Factors for Childhood-Onset Schizophrenia

Who Can Participate

Age: 6Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • INCLUSION CRITERIA:

    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).

EXCLUSION CRITERIA :

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

Status Unknown

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Reduced Functional Brain Activation and Connectivity During a Working Memory Task in Childhood-Onset Schizophrenia.

Frances F Loeb, Xueping Zhou, Kirsten E S Craddock...

https://pubmed.ncbi.nlm.nih.gov/29496125