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NCT06433843 Clinical Trial

FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome

Posttraumatic Stress Disorder Clinical Trial

Official title:
FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06433843
Other study ID # 090/2015BO2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date March 2020

Study information
Verified date May 2024
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the role FKBP5 DNA methylation levels in patients suffering from complex posttraumatic stress disorder, who participated in a 12-weeks disorder-specific DBT-PTSD inpatient treatment. DNA methylation levels were measured before and after completing DBT-PTSD.

Description:

Epigenetic modifications in the FKBP5 gene, which is involved in regulating the stress response, have been found to be associated with trauma-related mental disorders like posttraumatic stress disorder (PTSD). Previous research has suggested that FKBP5 may also be a predictor of therapy outcomes. However, there is limited evidence regarding its relationship with complex PTSD (cPTSD). This pilot study aimed to investigate the association between cPTSD and FKBP5 DNA methylation, as well as its predictive role in therapy outcomes among patients undergoing Dialectical Behavior Therapy for PTSD (DBT-PTSD), a 12-week trauma-focused inpatient treatment program. 29 patients with cPTSD who participated in the DBT-PTSD program were enrolled. FKBP5 DNA methylation levels were measured at two CpG sites before treatment (n=25) and after completing DBT-PTSD (n=15). To assess the predictive value of FKBP5 DNA methylation, we categorized the sample into responders and non-responders based on therapy outcome.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: complex posttraumatic stress disorder with or wothout comorbid borderline personality disorder Age between 18 and 65 Years Participiation in 12 weeks DBT-PTSD inpatient treatment Exclusion Criteria: Acute suicidality

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)
12 weeks inpatient disorder specific psychotherapy

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen Baden Württemberg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary DNA methylation levels of FKBP5 before and following DBT-PTSD FK506 binding protein 5 (FKBP5), an immunoregulator modulating glucocorticoid receptor activity, plays a key role in stress reactivity After 12 weeks of DBT-PTSD treatment
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