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NCT00001198 · ClinicalTrials.gov registry record

Evaluating Genetic Risk Factors for Childhood-Onset Schizophrenia

A clinical trial, sponsored by National Institute of Mental Health (NIMH).

Terminated
Registry status
1,556
Enrollment target

NCT00001198 is a clinical trial that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 1,556 participants.

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The verdict

NCT00001198 was terminated before completion, sponsored by National Institute of Mental Health (NIMH).

TERMINATED
Registry status
1,556 participants
Enrollment target

Study 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 mai

Trial Details

FieldValue
Enrollment Target 1,556 participants
Start Date 1984-03-19
Est. Completion 2017-10-10

What the Registry Record Tells You About NCT00001198

The ClinicalTrials.gov registry entry for NCT00001198 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 1,556 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00001198 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001198 about?

NCT00001198 is a clinical study titled "Evaluating Genetic Risk Factors for Childhood-Onset Schizophrenia". 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...

What is the current status of trial NCT00001198?

This trial is currently terminated. The enrollment target is 1,556 participants. The study started on 1984-03-19. Estimated completion is 2017-10-10.

Who is sponsoring clinical trial NCT00001198?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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