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

NCT01720953 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2014-07-25

No results posted yet for this study

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.

Conditions

  • Borderline Personality Disorder

Interventions

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.

Sponsors & Collaborators

  • Psychiatry Roskilde

    collaborator INDUSTRY
  • University of Copenhagen

    collaborator OTHER
  • Psychiatric Epigenetics Laboratory, Institute of Psychiatry, UK

    collaborator UNKNOWN
  • University of Southern Denmark

    collaborator OTHER
  • Psychoanalysis Unit, University College London, UK

    collaborator UNKNOWN
  • Aarhus University Hospital

    collaborator OTHER
  • University College Zealand, Denmark

    collaborator UNKNOWN
  • Research Division of Clinical Biochemistry, Koege Hospital, Denmark

    collaborator UNKNOWN
  • Rune Andersen

    lead OTHER

Principal Investigators

  • Erik Simonsen, Professor, MD, Ph.D. · Psychiatric Research Unit, Region Zealand, Denmark

  • Rune Andersen, Ph.D. · Psychiatric Research Unit, Region Zealand, Denmark

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

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View NCT01720953 on ClinicalTrials.gov