NCT01077687

Brief Summary

This proposal responds to Request for Applications RFA ( Rapid Founding Award)-MH ( Mental Health)-08-131, which seeks applications that propose to enrich pre-existing resources for schizophrenia in the NIMH ( National Institute of Mental Health) Human Genetics Initiative and to apply genomic methods to further our 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 SNP scanning. We, thus, collaborate with Professor Ming T, Tsuang and his extended subcontracted researchers to apply for this project. We, the research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. In our recently completed NIMH-funded Genetic Linkage Study of Schizophrenia (R01MH059624; USA PI: Ming T. Tsuang; Taiwan PI: Hai-Gwo Hwu), the investigators established a large and efficient ascertainment network and infrastructure in Taiwan, which will again be utilized and expanded in the proposed study. 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. 1.Rapidly ascertain schizophrenia trio families from ten Taiwanese clinical ascertainment sites;
  2. 2.Supplement NIMH Genetics Initiative collections by sending all clinical data and biomaterials to the appropriate repositories;
  3. 3.Assess the association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their constituent haplotypes;
  4. 4.Analyze quantitative schizophrenia phenotypes such as age at onset ;
  5. 5.Perform a genome-wide survey for copy-number variations related to schizophrenia;
  6. 6.Test for gene-gene interactions (epistasis); and
  7. 7.Test for gene-environment interactions, such as the well-established effect of season of birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

4.4 years

First QC Date

February 25, 2010

Last Update Submit

February 3, 2021

Conditions

Keywords

schizophreniagenome-wide association study (GWAS)single-nucleotide polymorphisms (SNPs)Han Chinese populationtrio familiesSchizophrenia with trio families

Eligibility Criteria

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

schizophrenia Han Chinese Population one sibling with his/her parents

You may qualify if:

  • Schizophrenia
  • Trio families (a proband's parents should be recruited)

You may not qualify if:

  • One or both parents of a proband was not alive
  • with mental retardation
  • with epilepsy
  • with alcohol or substance abuse
  • with other organic brain syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Hai-Gwo Hwu, Professor

    College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 1, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations