Trial Outcomes & Findings for Epigenetic Regulation of BDNF in Major Depression (NCT NCT01182103)
NCT ID: NCT01182103
Last Updated: 2014-08-15
Results Overview
averaged percentage of methylation at each CpG site listed
Recruitment status
COMPLETED
Target enrollment
110 participants
Primary outcome timeframe
2 years
Results posted on
2014-08-15
Participant Flow
From August 1st, 2000 to July 31st, 2012, major depressive disorder patients were recruited from Kaohsiung Chang Gung Memorial Hospital, a tertiary medical center.
Participant milestones
| Measure |
Major Depressive Patients
|
Healthy Subjects
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
62
|
|
Overall Study
COMPLETED
|
48
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epigenetic Regulation of BDNF in Major Depression
Baseline characteristics by cohort
| Measure |
Major Depressive Patients
n=48 Participants
|
Healthy Subjects
n=62 Participants
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.44 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
30.18 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
35.53 years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
48 participants
n=5 Participants
|
62 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Only 39 out of the 48 MDD patients provided enough blood sample for this analysis.
averaged percentage of methylation at each CpG site listed
Outcome measures
| Measure |
Major Depressive Patients
n=39 Participants
|
Healthy Subjects
n=62 Participants
|
Major Depressive Patients After Treatment
|
|---|---|---|---|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 324
|
95 percent
Standard Deviation 4.8
|
95 percent
Standard Deviation 2.4
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 24
|
92 percent
Standard Deviation 5.0
|
92 percent
Standard Deviation 3.0
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 57
|
75 percent
Standard Deviation 5.4
|
75 percent
Standard Deviation 4.8
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 80
|
65 percent
Standard Deviation 7.6
|
63 percent
Standard Deviation 6.2
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 134
|
87 percent
Standard Deviation 4.2
|
86 percent
Standard Deviation 3.8
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 140
|
49 percent
Standard Deviation 23.2
|
41 percent
Standard Deviation 24.7
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 177
|
93 percent
Standard Deviation 3.9
|
94 percent
Standard Deviation 2.3
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 203
|
88 percent
Standard Deviation 5.2
|
90 percent
Standard Deviation 2.9
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 217
|
61 percent
Standard Deviation 8.0
|
51 percent
Standard Deviation 11.4
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 327
|
88 percent
Standard Deviation 4.7
|
90 percent
Standard Deviation 2.5
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 345
|
97 percent
Standard Deviation 5.0
|
98 percent
Standard Deviation 3.0
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 348
|
90 percent
Standard Deviation 6.0
|
91 percent
Standard Deviation 4.1
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 362
|
89 percent
Standard Deviation 4.4
|
91 percent
Standard Deviation 2.0
|
—
|
|
Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls
CpG site 391
|
84 percent
Standard Deviation 4.8
|
85 percent
Standard Deviation 3.1
|
—
|
PRIMARY outcome
Timeframe: 2 yearsChromatin 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.
Outcome measures
| Measure |
Major Depressive Patients
n=39 Participants
|
Healthy Subjects
n=37 Participants
|
Major Depressive Patients After Treatment
n=37 Participants
|
|---|---|---|---|
|
Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls
BDNF promotor I acetyl-H3
|
3.5610 relative quantification
Standard Deviation 2.79865
|
.3124 relative quantification
Standard Deviation .53231
|
.4321 relative quantification
Standard Deviation .32039
|
|
Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls
BDNF promotor I acetyl-H4
|
2.6346 relative quantification
Standard Deviation 2.66175
|
.3784 relative quantification
Standard Deviation .54543
|
.4659 relative quantification
Standard Deviation .62056
|
|
Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls
BDNF promotor IV acetyl-H3
|
1.6356 relative quantification
Standard Deviation 2.33692
|
.4059 relative quantification
Standard Deviation .43157
|
.4303 relative quantification
Standard Deviation .70365
|
|
Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls
BDNF promotor IV acetyl-H4
|
2.2795 relative quantification
Standard Deviation 2.66175
|
.4676 relative quantification
Standard Deviation .54543
|
.4988 relative quantification
Standard Deviation .62056
|
|
Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls
BDNF promotor X acetyl-H3
|
3.8960 relative quantification
Standard Deviation 1.94450
|
.2564 relative quantification
Standard Deviation .36703
|
.3640 relative quantification
Standard Deviation .34533
|
|
Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls
BDNF promotor X acetyl-H4
|
1.7433 relative quantification
Standard Deviation 2.66175
|
.2105 relative quantification
Standard Deviation .30502
|
.2540 relative quantification
Standard Deviation .53050
|
SECONDARY outcome
Timeframe: 2 yearsSerum BDNF levels were measured. MDD patients received antidepressant treatment, a standard biological management. Nothing novel (such as experimental drugs or management) is introduced in the treatment, so the research design is observational (of standard treatment). 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.
Outcome measures
| Measure |
Major Depressive Patients
n=62 Participants
|
Healthy Subjects
n=48 Participants
|
Major Depressive Patients After Treatment
n=48 Participants
|
|---|---|---|---|
|
BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls
|
7.9386 ng/ml
Standard Deviation 3.24400
|
5.6014 ng/ml
Standard Deviation 4.46981
|
6.2803 ng/ml
Standard Deviation 5.58535
|
Adverse Events
Major Depressive Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place