Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Suspended
• CT.gov ID: NCT04095546
• Collaborator: Leading House for the Latin American Region (Seed Money Grant SMG 1730) (Other)
• Enrollment: 40
• Locations: 2
• Anticipated Duration (Months): 32
• Patients Per Site: 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder (BPD)	Other: routine psychotherapy for Borderline Personality Disorder (BPD)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Outcome Measures

Primary Outcome Measures

1. change in methylation of the FKBP5 gene [after 6 months from baseline]

   change in methylation of the FKBP5 gene

Secondary Outcome Measures

1. change in methylation of the FKBP5 gene [at month 3 and at month 12 after baseline.]

   change in methylation of the FKBP5 gene

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry and Mental Health, East Campus,	Santiago		Chile
2	Child and Adolescent Psychiatric Hospital, University Psychiatric Hospitals of the University of Basel	Basel		Switzerland	4056

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ronan Zimmermann, PhD, Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04095546
• Other Study ID Numbers: 2019-00658; pk19Zimmermann
• First Posted: Sep 19, 2019
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: epigenetic changes; Psychotherapy; epigenetic regulation; methylation patterns; change in methylation of genes; FKBP5 gene
• Additional relevant MeSH terms: Personality Disorders; Borderline Personality Disorder

Study Results

No Results Posted as of May 3, 2021