Ignite Creation Date:
2024-05-06 @ 2:49 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02134223
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2014-05-06
Brief Title:
Methylation Status of BDNF Gene After Dialectical Behavior Therapy in BPD
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
Changes in Methylation Status of BDNF Gene After Receiving Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Borderline personality disorder BPD is a chronic and debilitating syndrome associated with considerable morbidity mortality and high rates of medical and psychiatric utilization services Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention Recent research has implicated that brain-derived neutrophilic factor BDNF might be a natural candidate for a biological correlate of early life stress The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide and may later be able to explain the psychopathology or neuro-development of BPD
Method The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments and not TAU Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels Other clinical symptoms will as be assessed including suicidality depression hopelessness quality of life disability service utilization and function
In the first to third years of this study the investigators will aim to recruit 180 study and control subjects to gather information to collect biological samples to give out one-year of psychotherapy per subject to evaluate results before during and after treatment In addition the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level
Hypothesis
Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU
Method The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments and not TAU Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels Other clinical symptoms will as be assessed including suicidality depression hopelessness quality of life disability service utilization and function
In the first to third years of this study the investigators will aim to recruit 180 study and control subjects to gather information to collect biological samples to give out one-year of psychotherapy per subject to evaluate results before during and after treatment In addition the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level
Hypothesis
Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU
Detailed Description:
Background Borderline personality disorder BPD is a chronic and debilitating syndrome associated with considerable morbidity mortality and high rates of medical and psychiatric utilization services The prevalence of BPD is around 1-2 in general population However suicidality and self-injury are common an estimated 69-80 of patients with BPD attempt suicide and a higher percentage engage in nonsuicidal self-injurious behavior The rate of completed suicide in this group is appropriately 10 Several Western literature have demonstrated the therapeutic effects of dialectical behavior therapy DBT in patients with BPD However research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention Recent research has implicated that brain-derived neutrophilic factor BDNF might be a natural candidate for a biological correlate of early life stress The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide and may later be able to explain the psychopathology or neurodevelopment of BPD
Such studies investigating associations of changes in methylation levels with changes in depressive scores hopelessness scores impulsivity or effects of psychotherapy have never been done in Asian countries Little is known about the possible epigenetic changes related to Western psychological therapies for BPD patients in Asia
Method The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments and not treatment as usual TAU Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels Other clinical symptoms will as be assessed including suicidality depression hopelessness quality of life disability service utilization and function Inclusion criteria will be subjects who fulfill the Diagnostic Statistic Manual-IV DSM-IV criteria for BPD 20-60 years of age sign the informed consent have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years and at least one of which is in the 3 months preceding enrollment The exclusion criteria include psychotic disorder bipolar I disorder severe physical illness and mental retardation Outcome measures and blood samples will be obtained at pre-treatment 4-month 8-month and post-treatment 12-month during 1-year protocol Using semi-structured interview and a battery of self-report forms a range of symptoms and behaviors associated with BPD will be assessed Outcome variables will be evaluated by blinded assessors
In the first to third years of this study the investigators will aim to recruit 180 study and control subjects to gather information to collect biological samples to give out one-year of psychotherapy per subject to evaluate results before during and after treatment The TAU group would receive any therapy the patient could get excluding DBT In addition we also hope to explore the effects of known or unknown drugs associated with this project such as decitabine azacitidine trichostatin A valproic acid on the change of DNA methylation at cell level As a consequence considering potential developments of biological correlates or medications as future evidences of treatments for BPD this research is expected to take at least three years of investment
Primary hypothesis
Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU
Secondary Hypotheses
1 Participants who receive DBT and have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors will have different levels in BDNF methylations compared to those who didnt have as much improvement
2 Changes in scores or frequencies of borderline personality symptoms depression psychological symptoms suicidal ideation hopelessness disability and quality of life measures will be associated with changes in levels of BDNF proteins or BDNF methylations
3 Known or unknown epigenetic drugs are also associated with alterations in methylation status in patient with BPD at cell level
Such studies investigating associations of changes in methylation levels with changes in depressive scores hopelessness scores impulsivity or effects of psychotherapy have never been done in Asian countries Little is known about the possible epigenetic changes related to Western psychological therapies for BPD patients in Asia
Method The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments and not treatment as usual TAU Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels Other clinical symptoms will as be assessed including suicidality depression hopelessness quality of life disability service utilization and function Inclusion criteria will be subjects who fulfill the Diagnostic Statistic Manual-IV DSM-IV criteria for BPD 20-60 years of age sign the informed consent have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years and at least one of which is in the 3 months preceding enrollment The exclusion criteria include psychotic disorder bipolar I disorder severe physical illness and mental retardation Outcome measures and blood samples will be obtained at pre-treatment 4-month 8-month and post-treatment 12-month during 1-year protocol Using semi-structured interview and a battery of self-report forms a range of symptoms and behaviors associated with BPD will be assessed Outcome variables will be evaluated by blinded assessors
In the first to third years of this study the investigators will aim to recruit 180 study and control subjects to gather information to collect biological samples to give out one-year of psychotherapy per subject to evaluate results before during and after treatment The TAU group would receive any therapy the patient could get excluding DBT In addition we also hope to explore the effects of known or unknown drugs associated with this project such as decitabine azacitidine trichostatin A valproic acid on the change of DNA methylation at cell level As a consequence considering potential developments of biological correlates or medications as future evidences of treatments for BPD this research is expected to take at least three years of investment
Primary hypothesis
Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU
Secondary Hypotheses
1 Participants who receive DBT and have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors will have different levels in BDNF methylations compared to those who didnt have as much improvement
2 Changes in scores or frequencies of borderline personality symptoms depression psychological symptoms suicidal ideation hopelessness disability and quality of life measures will be associated with changes in levels of BDNF proteins or BDNF methylations
3 Known or unknown epigenetic drugs are also associated with alterations in methylation status in patient with BPD at cell level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MMH103-80 | OTHER_GRANT | None | None |
| MOST 103-2314-B-195-002-MY2 | OTHER_GRANT | Ministry of Science and TechnologyTaiwan | None |