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Epigenetic Regulation of BDNF in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01021449
First received: November 25, 2009
Last updated: November 27, 2009
Last verified: November 2009
History of Changes
  Purpose

In this proposal, we will (1) detect the associations between BDNF and Trk B gene DNA methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic drug responses in Taiwanese patients (2) discuss the possible mechanisms of epigenetic regulation of BDNF and Trk B in schizophrenia patients.


Condition
BDNF, DNA Methylation, Suicide, Drug Responses.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Epigenetic Regulation of BDNF and TrK B in Schizophrenic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • BDNF and Trk B DNA methylation, protein and mRNA levels [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the associations between BDNF and Trk B gene DNA methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic drug responses in Taiwanese patients [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 160
Study Start Date: December 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Healthy subjects
Schizophrenia
Schizophrenic patients

Detailed Description:

A total 160 subjects (80 subjects every year, including 40 healthy controls and 40 schizophrenia patients) will be recruited during a 2-year period. The first year, the baseline data of BDNF and Trk B DNA methylation, protein and mRNA levels in all subjects will be collected and the following 1 months data will also be collected in schizophrenia with antipsychotic drug treatments. The second year, the baseline data of BDNF and Trk B histone modification in all subjects will be collected.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This study will be conducted in our clinical setting. By a semi-structured interview for DSM-IV criteria, total 160 subjectes (80 subjects every year, including 40 healthy controls and 40 schizophrenia patients with acute exacerbation) will be recurited during a 2-year period. The data of blood BDNF and Trk B DNA methylation and histone remodelling of all subjects will be collected.

Criteria

Inclusion Criteria:

-

1. The clinical screening and assessment in schizophrenic patients：

  1. 40 schizophrenia patients will be recruited in psychiatric inpatients according to DSM-IV criteria (APA, 1994) by a structured interview (SCID). The assessment will be done by two senior psychiatrists. The intra-rater and inter-rater reliability will be done before this project started
  2. age : 18-65 years old.
  3. The patients had the ability to complete the written inform consent.。
  4. The choice of antipsychotic drugs depended on the need of patients in natural treatment procedure. They included conventional drugs, eg.haloperidol 10-20 mg/day；SDA (serotonin dopamine antagonist) drug, eg. clozapine 100-400 mg/day or risperidone 3-6mg/day. The choice of the medication was according to the need of patients including previous responses and side effects.
  5. PANSS (Positive and Negative Syndrome)(Kay, 1987,1988&1989) for positive, negative symptoms and severity.
  6. Check body mass index (BMI): if BMI<24: normal; 24<BMI<27: overweight; BMI>27: obesity (Taiwan criteria, 2004). If the patients were overweight or obesity, the lipid profiles would be done and we would consult the experts to assess these patients. The condition for diet control and daily activity will be observed. If the condition was extremely abnormal, the case will be excluded.
  7. Suicide behavior in tis study includes complete suicide and suicide attempt.

Exclusion Criteria:

  1. The patients had systemic diseases, including metabolic, heart, and liver diseases。
  2. The patients had received any drugs before entering this protocol.
  3. The patients were heavy smokers or dependent on alcohol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021449

Contacts
Contact: Tiao-Lai Huang, M.D. 886-7-7317123 ext 8753 a540520@adm.cgmh.org.tw

Locations
Taiwan
Department of Psychiatry, Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Tiao-Lai Huang, M.D.     886-7-7317123 ext 8753     a540520@adm.cgmh.org.tw    
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Tiao-Lai Huang, M.D. Chang-Gung Memorial Hospital, Kaohsiung
  More Information

No publications provided

Responsible Party: Tiao-Lai Huang, Head of Department of Psychiatry, Chang-Gung Memorial Hospital, Kaohsiung, Taiwan
ClinicalTrials.gov Identifier: NCT01021449     History of Changes
Other Study ID Numbers: CMRPG870951 and CMRPG870952
Study First Received: November 25, 2009
Last Updated: November 27, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
schizophrenia, BDNF, DNA methylation, histone modification

Additional relevant MeSH terms:
Schizophrenia
Suicide
Schizophrenia and Disorders with Psychotic Features
 Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013