Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

Borderline Personality Disorder (BPD) Clinical Trial

Official title:

Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04095546
• Other study ID #: 2019-00658; pk19Zimmermann
• Status: Withdrawn
• Start date: April 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Borderline Personality Disorder (BPD)
• Personality Disorders

Intervention

Other:
• routine psychotherapy for Borderline Personality Disorder (BPD)
Routine psychotherapy as treatment for patients with Borderline Personality Disorder

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Leading House for the Latin American Region (Seed Money Grant SMG 1730)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in methylation of the FKBP5 gene	change in methylation of the FKBP5 gene	after 6 months from baseline
Secondary	change in methylation of the FKBP5 gene	change in methylation of the FKBP5 gene	at month 3 and at month 12 after baseline.