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Clinical Trials/NCT01021449
NCT01021449
Completed
Not Applicable

Epigenetic Regulation of BDNF and TrK B in Schizophrenic Patients

Chang Gung Memorial Hospital1 site in 1 country129 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
BDNF, DNA Methylation, Suicide, Drug Responses.
Sponsor
Chang Gung Memorial Hospital
Enrollment
129
Locations
1
Primary Endpoint
BDNF and Trk B DNA methylation, protein and mRNA levels
Status
Completed
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
November 2010
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tiao-Lai Huang

Head of Department of Psychiatry

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • The clinical screening and assessment in schizophrenic patients:
  • 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
  • age : 18-65 years old.
  • The patients had the ability to complete the written inform consent.。
  • 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.
  • PANSS (Positive and Negative Syndrome)(Kay, 1987,1988\&1989) for positive, negative symptoms and severity.
  • 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.
  • Suicide behavior in tis study includes complete suicide and suicide attempt.

Exclusion Criteria

  • The patients had systemic diseases, including metabolic, heart, and liver diseases。
  • The patients had received any drugs before entering this protocol.
  • The patients were heavy smokers or dependent on alcohol.

Outcomes

Primary Outcomes

BDNF and Trk B DNA methylation, protein and mRNA levels

Time Frame: Two years

Secondary Outcomes

  • 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)

Study Sites (1)

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