Epigenetic Regulation of BDNF in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tiao-Lai Huang, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01021449
First received: November 25, 2009
Last updated: September 11, 2013
Last verified: September 2013

November 25, 2009
September 11, 2013
December 2008
November 2010   (final data collection date for primary outcome measure)
BDNF and Trk B DNA methylation, protein and mRNA levels [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01021449 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Epigenetic Regulation of BDNF in Schizophrenia
Epigenetic Regulation of BDNF and TrK B in Schizophrenic Patients

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

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.

BDNF, DNA Methylation, Suicide, Drug Responses.
Not Provided
  • Control
    Healthy subjects
  • Schizophrenia
    Schizophrenic patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01021449
CMRPG870951 and CMRPG870952
No
Tiao-Lai Huang, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Tiao-Lai Huang, M.D. Chang-Gung Memorial Hospital, Kaohsiung
Chang Gung Memorial Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP