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WithdrawnNCT04095546Updated Sep 13, 2022

Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

An observational study in Borderline Personality Disorder (BPD), sponsored by University Hospital, Basel, Switzerland. Withdrawn. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by University Hospital, Basel, Switzerland · Observational

Why this study was withdrawn
personal changes in study team
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
14 Years to 18 Years
Sex
All
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Study summary

The link between epigenetic changes as an effect of psychotherapy has been investigated recently. Genes investigated in these studies were brain-derived neurotrophic factor (BDNF), NR3C1, FKBP51, MAOA and GLUT1. Change in methylation of these genes could be a biomolecular mechanism of psychotherapy induced changes. This study project aims at providing evidence for a biological mechanism of personality disorder interventions in adolescence by investigating the link between epigenetic changes as an effect of psychotherapy. It investigates the correlation between changes in the methylation of the FKBP5 gene and psychotherapy induced changes in symptoms and functioning.

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Conditions studied

  • Borderline Personality Disorder (BPD)

Keywords

  • epigenetic changes
  • Psychotherapy
  • epigenetic regulation
  • methylation patterns
  • change in methylation of genes
  • FKBP5 gene
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In context

Personality Disorders

336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.

Browse Personality Disorders studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients in Basel/ Switzerland will be recruited from the routine clinical practice of the Outpatient Department of the Child and Adolescent Psychiatric Hospital.

Patients in Santiago/ Chile will be recruited from the Department of Psychiatry and Mental Health, East Campus,Faculty of Medicine, University of Chile.

Inclusion criteria

  • adolescents presenting 3 or more criteria for BPD in the Structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) axis II personality disorders (SCID-II)

Exclusion criteria

Exclusion Criteria:

  • difficulties to understand or comply with instructions
  • psychotic disorders
  • pervasive developmental disorders
  • severe somatic or neurological disorders
  • severe and persistent substance addiction
  • elevated risk for complications related to blood sampling
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • Otherroutine psychotherapy for Borderline Personality Disorder (BPD)

    Routine psychotherapy as treatment for patients with Borderline Personality Disorder

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What researchers measure

Primary outcomes

  1. change in methylation of the FKBP5 gene

    change in methylation of the FKBP5 gene

    Time frame: after 6 months from baseline

Secondary outcomes

  1. change in methylation of the FKBP5 gene

    change in methylation of the FKBP5 gene

    Time frame: at month 3 and at month 12 after baseline.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04095546
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Leading House for the Latin American Region (Seed Money Grant SMG 1730)
Responsible party
Sponsor
First posted
Sep 19, 2019
Start date
Apr 2022 (estimated)
Primary completion
Feb 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Sep 13, 2022

Study contacts

Ronan Zimmermann, PhD
principal investigator · Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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