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Methylation Status of BDNF Gene After Dialectical Behavior Therapy in BPD

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ClinicalTrials.gov Identifier: NCT02134223
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Mackay Memorial Hospital

Brief Summary:

Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neuro-development of BPD.

Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function.

In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. In addition, the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level.

Hypothesis:

Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.


Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Dialectical behavior therapy Other: Treatment as Usual: any other drug or psychotherapy offered to participants, except DBT Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Changes in Methylation Status of BDNF Gene After Receiving Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Study Start Date : April 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dialectical behavior therapy
Primary intervention group: receiving one year of dialectical behavior therapy
Behavioral: Dialectical behavior therapy

in standard DBT, we will employ all treatment modalities: a weekly individual (1 hour) and group (2 hours) session, available telephone consultation, and DBT consultation team.

DBT participants will be assigned to the next available individual therapist and relevant skills training group.

Groups have a minimum of four members before commencement and a maximum of twelve members. Entry to the skills group occurs only at the commencement of the next skills module.


Placebo Comparator: treatment as usual
Comparison group: receiving one year of treatment as usual
Other: Treatment as Usual: any other drug or psychotherapy offered to participants, except DBT
No Intervention: Receiving no treatment at all
Healthy control group



Primary Outcome Measures :
  1. Borderline Symptom Checklist (BSL-23) [ Time Frame: Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment ]
    To measure whether there were changes in scores of each symptoms regarding borderline personality disorder, such as number of times of attempting suicide, number of times of attempting self-harm, number of times of feeling emptiness, number of times of dissociations, number of times of risk-taking behaviors, number of times of substance or alcohol misuse etc.


Secondary Outcome Measures :
  1. The Patient Health Questionnaire (PHQ-9) [ Time Frame: Changes in scores of PHQ-9 before and at 4, 8, 12 months after starting the treatment ]
    To measure changes in levels of patient health on a 4-point likert scale over questions of : feeling lack of interest? feeling sad or hopelessness, having problems sleeping, feeling fatigue or lack of energy, feeling poor appetite, or hyperphagia, feeling lack of confidence, unable to concentrate, or restlessness.


Other Outcome Measures:
  1. Symptom Checklist-90-Revised (SCL-90-R) [ Time Frame: Changes in scores before and at 4, 8, 12 months after starting the treatment ]
    To measure the following feelings within the week prior to assessment on a 5-point likert scale on items of whether having headache, dizziness, lack of interest, feeling guilty, sense of being control, blaming others for making troubles, forgetfulness, chest tightness, easy worrying, decreased energy level, suicidal ideation, auditory hallucinations, fearful, irritability, feeling lonely, palpitation, nausea, persecutory ideations, referential ideations, shortness of breath, numbness sensation, foreign body sensation, easy nervous, violent impulse, felt much difficulty in doing everything, or argumentative.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. patients meeting DSM-IV criteria for borderline personality disorder,
  2. 18-60 years of age
  3. have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years
  4. at least one of which is in the 3 months preceding enrollment
  5. agreement to participate in evaluation of the program

Exclusion Criteria:

  1. having a DSM-IV diagnosis of a psychotic disorder, bipolar I disorder, delirium, dementia, mental retardation, or a diagnosis of substance dependence in the preceding 30 days
  2. living outside of Taipei area
  3. having any serious medical condition likely to require hospitalization within the next year (e.g. cancer)
  4. having plans to leave the Taipei area in the next 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134223


Contacts
Contact: Shu-I Wu, MD, PhD +886-2-88094661 ext 3055 shuiwu624@gmail.com

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 251
Contact: Shu-I Wu, MD, PhD    +886-2-88094661 ext 3055    shuiwu624@gmail.com   
Sponsors and Collaborators
Mackay Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: Shu-I Wu, MD, PhD Mackay Memorial Hospital, Taipei, Taiwan

Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT02134223     History of Changes
Other Study ID Numbers: 13MMHIS257
MMH103-80 ( Other Grant/Funding Number: Mackay Memorial Hospital )
MOST 103-2314-B-195-002-MY2 ( Other Grant/Funding Number: Ministry of Science and Technology,Taiwan )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders