Epigenetic Regulation of BDNF in Major Depression

NCT01182103 | Completed Results

• 1 other identifier: NSC99-2628-B-182-002-MY2
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will (1) detect the associations between brain-derived neurotrophic factor (BDNF) DNA methylation, histone modification, depressive symptoms, suicidal behavior and antidepressant responses in major depressive disorder (MDD) patients, (2) check the correlation between blood BDNF protein and RNA and BDNF rs6265 gene, and (3) discuss the possible mechanisms of epigenetic regulation of BDNF in Taiwanese major depressive patients.

Conditions

Major Depressive Disorder

Keywords

Major depression; BDNF; DNA methylation; Histone modification

Outcome Measures

Primary Outcomes (2)

• Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls

  averaged percentage of methylation at each CpG site listed

  2 years

• Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls

  Chromatin immunoprecipitation (ChIP) was used to measure histone modification. The unit of our given machine is relative quantification, and a higher value indicated increased histone modification. The detailed method could be found in: Huebert DJ, Kamal M, O'Donovan A, Bernstein BE: Genome-wide analysis of histone modifications by ChIP-on-chip. Methods 2006; 40: 365-369.

  2 years

Secondary Outcomes (1)

• BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls

  2 years

Study Arms (2)

Major depressive patients

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This 2-year study will be conducted in our clinical setting. By a semi-structured interview for DSM-IV criteria, a total of 160 subjectes (80 healthy controls and 80 patients with major depression) will be recruited in this study. In the first year (recruiting 40 healthy controls and 40 patients with major depression), the data of BDNF DNA methylation in all subjects will be collected. In the second year (recruiting another 40 healthy controls and 40 patients with major depression), the data of BDNF histone modification in all subjects will be collected and the mechanism of epigenetic regulation of BDNF in major depression will be discussed.

You may qualify if:

• The clinical screening and assessment in patients with major depression：
• major depression will be recruited in psychiatric inpatients according to DSM-IV criteria by a semi-structured interview. The assessment will be done by two senior psychiatrists. The intra-rater and inter-rater reliability will be done before this project started.
• The patients had the ability to complete the written inform consent.
• The choice of antidepressant drugs depended on the need of patients in natural treatment procedure. They included selective serotonin reuptake inhibitors (SSRI), eg. fluoxetine or paroxetine.
• The 17-item Hamilton Depression Rating Scale (HAM-D) was used to assess severity of depression. The minimum baseline score of the 17-item HAM-D was 18.

You may not qualify if:

• 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.
• The use of secondary generation anti-psychotic drugs and mood stabilizers.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Psychiatry, Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

Limited funding prevented all samples from receiving all analyses.

Results Point of Contact

• Title: Tiao-Lai Huang
• Organization: Kaohsiung Chang Gung Memorial Hospital

a540520@adm.cgmh.org.tw

886-7-7317123

Study Officials

• Tiao-Lai Huang, M.D.

  Chang-Gung Memorial Hospital, Kaohsiung

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Psychiatry

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 16, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

TW (1)