Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

NCT04095546 | Withdrawn

• 1 other identifier: 2019-00658; pk19Zimmermann
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Borderline Personality Disorder (BPD)

Keywords

epigenetic changes; Psychotherapy; epigenetic regulation; methylation patterns; change in methylation of genes; FKBP5 gene

Outcome Measures

Primary Outcomes (1)

• change in methylation of the FKBP5 gene

  change in methylation of the FKBP5 gene

  after 6 months from baseline

Secondary Outcomes (1)

• change in methylation of the FKBP5 gene

  at month 3 and at month 12 after baseline.

Interventions

routine psychotherapy for Borderline Personality Disorder (BPD) OTHER

Routine psychotherapy as treatment for patients with Borderline Personality Disorder

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Leading House for the Latin American Region (Seed Money Grant SMG 1730): collaborator

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Ronan Zimmermann, PhD

  Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: April 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09