Epigenetic Regulation of BDNF in Schizophrenia

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01021449
Collaborator
(none)
129
1
23
5.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    129 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Epigenetic Regulation of BDNF and TrK B in Schizophrenic Patients
    Study Start Date :
    Dec 1, 2008
    Actual Primary Completion Date :
    Nov 1, 2010
    Actual Study Completion Date :
    Nov 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Healthy subjects

    Schizophrenia

    Schizophrenic patients

    Outcome Measures

    Primary Outcome Measures

    1. BDNF and Trk B DNA methylation, protein and mRNA levels [Two years]

    Secondary Outcome Measures

    1. the associations between BDNF and Trk B gene DNA methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic drug responses in Taiwanese patients [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. The clinical screening and assessment in schizophrenic patients:

    2. 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

    3. age : 18-65 years old.

    4. The patients had the ability to complete the written inform consent.。

    5. 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.

    6. PANSS (Positive and Negative Syndrome)(Kay, 1987,1988&1989) for positive, negative symptoms and severity.

    7. 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.

    8. 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

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry, Chang Gung Memorial Hospital Kaohsiung Taiwan 833

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Principal Investigator: Tiao-Lai Huang, M.D., Chang-Gung Memorial Hospital, Kaohsiung

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tiao-Lai Huang, Head of Department of Psychiatry, Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT01021449
    Other Study ID Numbers:
    • CMRPG870951 and CMRPG870952
    First Posted:
    Nov 30, 2009
    Last Update Posted:
    Sep 12, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Tiao-Lai Huang, Head of Department of Psychiatry, Chang Gung Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 12, 2013