Epigenetic Changes in Psychotherapy of Adolescents With B... | NCT04095546

Studies
Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

NCT04095546

Sponsor

University Hospital, Basel, Switzerland

Status

Withdrawn

Last Update Posted

Sep 13, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Borderline Personality Disorder (BPD)

Interventions

routine psychotherapy for Borderline Personality Disorder (BPD)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

personal changes in study team

Expanded Access Info

Start Date

Apr 2022Estimated

Primary Completion Date

Feb 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Sep 17, 2019

First Submission Date that Met QC Criteria

Sep 17, 2019

First Posted Date

Sep 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2022

Last Update Posted Date

Sep 13, 2022Actual

Name	Class
Leading House for the Latin American Region (Seed Money Grant SMG 1730)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
routine psychotherapy for Borderline Personality Disorder (BPD)	Other	Routine psychotherapy as treatment for patients with Borderline Personality Disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in methylation of the FKBP5 gene	change in methylation of the FKBP5 gene	after 6 months from baseline

Secondary Outcomes

Measure	Description	Time Frame
change in methylation of the FKBP5 gene	change in methylation of the FKBP5 gene	at month 3 and at month 12 after baseline.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronan Zimmermann, PhD	Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided