NCT01362478

Brief Summary

Schizophrenia is a disabling mental disease affecting about 1% of the worldwide population. There is an overall heritability estimate of 68% for the underlying liability to schizophrenia. Molecular epigenetic studies can overcome the complexities of traditional genetic studies and provide a new framework for the search of etiological factors in schizophrenia. DNA methylation provides an example of an epigenetic process that affects gene expression. Several postmortem experiments have found that increased DNA methylation at the glutamic acid decarboxylase (GAD67) and reelin promoter, and hypomethylation of membrane-bound catechol-O-methyltransferase (MB-COMT) promoter gene in prefrontal cortex of schizophrenia patients. Because it is impossible to obtain brain tissue from schizophrenia patients clinically, the peripheral blood mononuclear cell (PBMC) can partly represent the brain gene expression. It has been reported to use PBMC as biomarkers for epigenetic abnormalities, such as histone acetylation and methylation, in schizophrenia. To the investigators best knowledge, gene promoter DNA methylation abnormalities in schizophrenia have been limited to postmortem study. It warrants to studying the DNA methylation using schizophrenia's PBMC. Recently, endophenotype strategy has emerged as an important tool in understanding the genetic architecture of schizophrenia. Some cognitive functions, such as attention and working memory (WM), have been used as candidate endophenotypes for genetic studies in schizophrenia. Synchronized GABA neurotransmission in the dorsolateral prefrontal cortex is required for adequate attention and working memory, suggesting that impairments in GABA-mediated inhibition in the prefrontal cortex could contribute to the endophenotype presentations in schizophrenia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

First QC Date

May 26, 2011

Last Update Submit

June 27, 2012

Conditions

Keywords

schizophreniagene promotermethylationendophenotypeepigenetic

Study Arms (2)

Case group

Control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

schizophrenia patients

You may qualify if:

  • age 20-65 year-old
  • fulfill DSM-IV criteria of schizophrenia

You may not qualify if:

  • patients who are pregnant or have significant medical conditions
  • unstable psychiatric features (e.g. suicidal), too agitation
  • a history of substance abuse or drug addiction within the previous 6 months, with the exception of nicotine dependence.
  • Control
  • year-old
  • to have major psychiatric disorder, such as schizophrenia, mood disorders, and substance use disorders, except nicotine
  • to have family history of schizophrenia, mood disorders, and substance use disorders
  • to have serious medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

WanFang Hospital, Taipei Medical University

Taipei, Taiwan, 116, Taiwan

RECRUITING

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gene promoter DNA methylations

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Chun-Hsin Chen

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hsin Chen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff, Department of Psychiatry

Study Record Dates

First Submitted

May 26, 2011

First Posted

May 30, 2011

Study Start

August 1, 2011

Study Completion

July 1, 2014

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations