NCT01249079

Brief Summary

This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications that propose to enrich pre-existing resources for schizophrenia in the National Institute of Mental Health (NIMH) Human Genetics Initiative and to apply genomic methods to further the investigators understanding of the molecular etiology of the disorder. The overarching aims of this proposal are to quickly and cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to discover causal variants for the disorder in the first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind of GWAS study as it is a very expensive study, including collecting large family samples and genome-wide single-nucleotide polymorphism (SNP) scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his entended subcontracted researchers to apply for this project. The investigators, the research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. Through additional ascertainment within this framework, the investigators will collect an aggregate sample with adequate power for detecting in a GWAS those variants that make even small contributions to the risk for the disorder. The investigators will meet the overarching goals of this project by accomplishing several Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending all clinical data and biomaterials to the appropriate repositories; 3) Assess the association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6) Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions, such as the well-established effect of season of birth.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

December 1, 2010

Status Verified

October 1, 2010

Enrollment Period

3.2 years

First QC Date

November 24, 2010

Last Update Submit

November 30, 2010

Conditions

Study Arms (1)

Schizophrenia Family

Other: No intervention would be provided in this research

Interventions

No intervention would be provided in this research,but need to draw blood

Schizophrenia Family

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Schizophrenia patients and their biological parents

You may qualify if:

  • clinical diagnosis of schizophrenia and their parents, and parents are still alive

You may not qualify if:

  • person with Mental Retardation
  • persons with epilepsy
  • alcohol or substance abuse combined
  • in combination with other organic brain damage syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Hsien-Yuan Lane

    China Medical University Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 29, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2013

Last Updated

December 1, 2010

Record last verified: 2010-10

Locations