SchizophreniaNCT01362478
Gene Promoter DNA Methylations and Their Relationships With Endophenotypes in Patients With Schizophrenia
An observational study of Schizophrenia, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- Aug 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: schizophrenia patients
Who may be able to join
- age 20-65 year-old
- fulfill DSM-IV criteria of schizophrenia
- 20-65 year-old
Who cannot join
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
WanFang Hospital, Taipei Medical University
Taipei, Taiwan, 116
Chun-Hsin Chen, MD, 886-2-29307930 ext. 53961, chunhsin57@yahoo.com.tw
Chun-Hsin Chen, MD
- Not yet recruiting
Taipei Medical University - WanFang Hospital
Taipei
Chun-Hsin Chen, 886-2-29307930 ext. 53961, chunhsin57@yahoo.com.tw
About this study
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.
Read more
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.
Read the detailed description
The study will be approved by Institutional Review Board of participated institutions before recruiting patients. We will recruit 60 patients with schizophrenia and 60 healthy control subjects after explaining the study goal and getting the informed consents.
We will evaluate the performance of continuous performance test (CPT) and working memory subset in Chinese version of WAIS-III in both case and control subjects. We will assay reelin, GAD, and MB-COMT gene promoter DNA methylation using methylation specific PCR (MSP) and quantify these gene expression using quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Patients will be followed in one year and receive the same evaluation.
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, gene promoter, methylation, endophenotype, epigenetic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Not described | |
| Control group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startAug 2011
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Hsin Chen, Taipei Medical University WanFang Hospital
- Investigators
- Chun-Hsin Chen, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362478
- Sponsor's protocol ID
- 99083
- Status last verified
- Jun 2012
- First submitted
- 26 May 2011
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Promoter DNA Methylations and Their Relationships With Endophenotypes in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01362478
- Acronym / sponsor ID
- 99083
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, gene promoter, methylation, endophenotype, epigenetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Study completion
- Jul 2014 (estimated)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be approved by Institutional Review Board of participated institutions before recruiting patients. We will recruit 60 patients with schizophrenia and 60 healthy control subjects after explaining the study goal and getting the informed consents.
We will evaluate the performance of continuous performance test (CPT) and working memory subset in Chinese version of WAIS-III in both case and control subjects. We will assay reelin, GAD, and MB-COMT gene promoter DNA methylation using methylation specific PCR (MSP) and quantify these gene expression using quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Patients will be followed in one year and receive the same evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- schizophrenia patients
Key inclusion criteria (3 listed)
- age 20-65 year-old
- fulfill DSM-IV criteria of schizophrenia
- 20-65 year-old
Key exclusion criteria (7 listed)
- 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
- to have major psychiatric disorder, such as schizophrenia, mood disorders, and substance use disorders, except nicotine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Hsin Chen principal investigator
Taipei Medical University WanFang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Hsin Chen, MD (886-2-29307930 ext. 53961, chunhsin57@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.