N/A
Completed N=110
Epigenetic Regulation of BDNF in Major Depression
Source: ClinicalTrials.gov NCT01182103 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls — 92; 92; 75; 75 percent — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls |
92; 92; 75; 75; 65; 63 | <0.05 sig |
| PRIMARY Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls |
3.5610; .3124; .4321; 2.6346; .3784; .4659 | <0.05 sig |
| SECONDARY BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls |
7.9386; 5.6014; 6.2803 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
The clinical screening and assessment in patients with major depression：
- 40 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.
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.
- The use of secondary generation anti-psychotic drugs and mood stabilizers.
Data sourced from ClinicalTrials.gov (NCT01182103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.