Neuropsychiatric Mechanisms of Change in Mentalization Based Treatment of Borderline Personality Disorder (MENTAB)

Borderline Personality Disorder Clinical Trial

— MENTAB  

Official title:

Neuropsychiatric Mechanisms of Change in Mentalization Based Treatment of Borderline Personality Disorder (MENTAB)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01720953
• Other study ID #: SJ-311
• Status: Terminated
• Phase: N/A
• First received: October 26, 2012
• Last updated: July 24, 2014
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: Region Sjælland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Patients:

Inclusion Criteria:

• Female patients between the ages 18 - 40 with a clinical diagnosis of Borderline Personality Disorder to undergo a year of Mentalization Based Therapy at the Psychiatric Clinic Roskilde.

Exclusion Criteria:

• Severe comorbidity

• Serious medical condition

• Pregnancy

Healthy control subjects:

Inclusion Criteria:

• Match patients on age, gender, and socioeconomic status.

Exclusion Criteria:

• Any mental disorder

• Serious medical condition

• Pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Other:
• Mentalization Based Therapy
Fifty female patients diagnosed with BPD will undergo a year of intensive Mentalization Based Therapy that is designed to target domains of BPD pathology. The patients will be assessed at baseline and every 6 months over the treatment period.

Locations

Country	Name	City	State
Denmark	Psychiatric Research Unit, Region Zeland	Roskilde

Sponsors (9)

Lead Sponsor	Collaborator
Rune Andersen	Aarhus University Hospital, Psychiatric Epigenetics Laboratory, Institute of Psychiatry, UK, Psychiatry Roskilde, Psychoanalysis Unit, University College London, UK, Research Division of Clinical Biochemistry, Koege Hospital, Denmark, University College Zealand, Denmark, University of Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Promoter methylation pattern of genes considered to be related to the development and pathology of BPD, in particular the BDNF and glucocorticoid receptor genes		Assessed at baseline, and after 6 and 12 months	No
Primary	BDNF serum levels		Assessed at baseline, and after 6 and 12 months	No
Primary	Salivary cortisol levels		Assessed at baseline, and after 6 and 12 months	No
Primary	Neuropsychological test performance	Assessed by a comprehensive battery of neuropsychological tests to measure both cognitive and emotion processing, including standard paper-and-pencil tests (WAIS-IV) and selected computerized tests (CANTAB, SuperLab and E-Prime). An interview will be conducted to assess autobiographical memory function.	Assessed at baseline and after 12 months	No
Primary	Psychopathology	Measured by Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), Hamilton Rating Scale for Depression (HAM-D), Symptom Checklist-90-Revised (SCL-90-R), Severity Indices of Personality Problems (SIPP-118), and Dissociative Experiences Scale - Brief (DES-B)	Assessed before baseline, and after 6 and 12 months	No
Primary	Affect regulation	Measured by Affective Lability Scale (ALS-18), Barratt Impulsiveness Scale (BIS-11), Buss-Perry Aggression Questionnaire (BPAQ), Toronto Alexithymia Scale (TAS-20)	Assessed at baseline, and after 6 and 12 months	No