Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01720953
Status:
TERMINATED
Last Update Posted:
2014-07-25
First Post:
2012-10-26
Brief Title:
Neuropsychiatric Mechanisms of Change in Mentalization Based Treatment of Borderline Personality Disorder MENTAB
Sponsor:
Rune Andersen
Organization:
Region Sjælland
Study Overview
Official Title:
Neuropsychiatric Mechanisms of Change in Mentalization Based Treatment of Borderline Personality Disorder MENTAB
Status:
TERMINATED
Status Verified Date:
2014-07
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:
MENTAB
Brief Summary:
Purpose
Borderline personality disorder BPD is a complex psychiatric disease of uncertain aetiology and pathogenesis A key mechanism of disease susceptibility and treatment response could be epigenetic changes in DNA methylation patterns However no study has yet demonstrated that psychotherapy can exert its therapeutic effect through epigenetic mechanisms The main aim of this study is to analyze the promoter methylation pattern of genes considered to be related to the development and psychopathology of BPD in particular the brain-derived neurotrophic factor BDNF and glucocorticoid receptor genes and the effects of mentalization based treatment MBT on changes Associations to changes in BDNF serum levels and salivary cortisol levels as well as key components of BPD aetiology and core treatment targets in MBT will also be investigated Should epigenetic mechanisms have importance for BPD pathology and effects of treatment there is potential use of DNA methylation patterns as valid biomarker measures of diagnosis prognosis and treatment response
Hypothesis
The formation and maintenance of symptoms in BPD is mediated through neuropsychiatric mechanisms that can be affected through psychological treatment Specifically aberrant epigenetic regulation of neuropsychiatric genes related to behavioural control and affect regulation as well as BDNF and cortisol levels is ameliorated by therapeutic processes
Method
Fifty female patients diagnosed with BPD will undergo a year of intensive MBT that is designed to target domains of BPD pathology The patients will be assessed at baseline and every 6 months over the treatment period Matched healthy control subjects will be assessed at 6 month intervals to compare changes in DNA methylation BDNF serum levels salivary cortisol levels and neuropsychological test performance To link components of the neuropsychiatric mechanisms underlying the onset of illness course and response to treatment patients will undergo assessment of clinical symptoms comorbidity patterns and psychosocial impairment Patients and control subjects will at baseline undergo assessment for childhood trauma self-harm suicidal behavior early maladaptive schemas and personality traits and within the 1-year study period also undergo continuous assessment for changes in symptoms of dissociation depression and personality dysfunction
Borderline personality disorder BPD is a complex psychiatric disease of uncertain aetiology and pathogenesis A key mechanism of disease susceptibility and treatment response could be epigenetic changes in DNA methylation patterns However no study has yet demonstrated that psychotherapy can exert its therapeutic effect through epigenetic mechanisms The main aim of this study is to analyze the promoter methylation pattern of genes considered to be related to the development and psychopathology of BPD in particular the brain-derived neurotrophic factor BDNF and glucocorticoid receptor genes and the effects of mentalization based treatment MBT on changes Associations to changes in BDNF serum levels and salivary cortisol levels as well as key components of BPD aetiology and core treatment targets in MBT will also be investigated Should epigenetic mechanisms have importance for BPD pathology and effects of treatment there is potential use of DNA methylation patterns as valid biomarker measures of diagnosis prognosis and treatment response
Hypothesis
The formation and maintenance of symptoms in BPD is mediated through neuropsychiatric mechanisms that can be affected through psychological treatment Specifically aberrant epigenetic regulation of neuropsychiatric genes related to behavioural control and affect regulation as well as BDNF and cortisol levels is ameliorated by therapeutic processes
Method
Fifty female patients diagnosed with BPD will undergo a year of intensive MBT that is designed to target domains of BPD pathology The patients will be assessed at baseline and every 6 months over the treatment period Matched healthy control subjects will be assessed at 6 month intervals to compare changes in DNA methylation BDNF serum levels salivary cortisol levels and neuropsychological test performance To link components of the neuropsychiatric mechanisms underlying the onset of illness course and response to treatment patients will undergo assessment of clinical symptoms comorbidity patterns and psychosocial impairment Patients and control subjects will at baseline undergo assessment for childhood trauma self-harm suicidal behavior early maladaptive schemas and personality traits and within the 1-year study period also undergo continuous assessment for changes in symptoms of dissociation depression and personality dysfunction
Detailed Description:
None
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