Borderline Personality Disorder (BPD)NCT04095546
Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology
An observational study of Borderline Personality Disorder (BPD), run by University Hospital, Basel, Switzerland.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- routine psychotherapy for Borderline Personality Disorder (BPD)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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)
- Being tested
- routine psychotherapy for Borderline Personality Disorder (BPD)
- Keywords
- epigenetic changes, Psychotherapy, epigenetic regulation, methylation patterns, change in methylation of genes, FKBP5 gene
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine psychotherapy for Borderline Personality Disorder (BPD)Other
Routine psychotherapy as treatment for patients with Borderline Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
change in methylation of the FKBP5 gene
change in methylation of the FKBP5 gene
Measured: after 6 months from baseline
Secondary outcomes (1)
change in methylation of the FKBP5 gene
change in methylation of the FKBP5 gene
Measured: at month 3 and at month 12 after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study startApr 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: personal changes in study team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Leading House for the Latin American Region (Seed Money Grant SMG 1730)
- Responsible party
- Sponsor
- Investigators
- Ronan Zimmermann, PhD, Principal investigator, Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095546
- Sponsor's protocol ID
- 2019-00658; pk19Zimmermann
- Other IDs
- 2019
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology
- ClinicalTrials.gov ID
- NCT04095546
- Acronym / sponsor ID
- 2019-00658; pk19Zimmermann
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- epigenetic changes, Psychotherapy, epigenetic regulation, methylation patterns, change in methylation of genes, FKBP5 gene
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: personal changes in study team
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Leading House for the Latin American Region (Seed Money Grant SMG 1730)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- difficulties to understand or comply with instructions
- psychotic disorders
- pervasive developmental disorders
- severe somatic or neurological disorders
- severe and persistent substance addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine psychotherapy for Borderline Personality Disorder (BPD)Routine psychotherapy as treatment for patients with Borderline Personality Disorder | Other | – |
Primary outcome
change in methylation of the FKBP5 gene
Time frame: after 6 months from baseline
change in methylation of the FKBP5 gene
1 secondary outcome
change in methylation of the FKBP5 gene
Time frame: at month 3 and at month 12 after baseline.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronan Zimmermann, PhD principal investigator
Kinder- und Jugendpsychiatrische Klinik/Universitäre Psychiatrische Klinken Basel (UPK)
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder (BPD), run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in methylation of the FKBP5 gene (time frame: after 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.