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| Descriptive Information Fields | |||||||||
| Brief Title † | Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder | ||||||||
| Official Title † | Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder | ||||||||
| Brief Summary | This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder. |
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| Detailed Description | Borderline personality disorder (BPD) can be a serious and very complex condition. BPD affects 2% to 3% of the population and is more commonly diagnosed in young women. BPD is characterized by mood swings, impulsive behavior, difficulty controlling emotions, and acting out inappropriately either through self-harm or attempts of suicide. Other illnesses such as depression and anxiety are also very common in people diagnosed with BPD. Various treatments exist that aim to reduce self-harm and suicide among people with BPD. Dialectical behavior therapy (DBT), an outpatient behavioral therapy shown to help self-injurious patients with BPD, has become a popular treatment. Another useful treatment, the antidepressant fluoxetine, can help to regulate mood and diminish suicidal or self-destructive urges. Although combination treatments of DBT and fluoxetine are common, little research has been conducted on the effectiveness of this kind of combined treatment. The purpose of this study is to determine whether DBT and fluoxetine are more effective combined or alone in treating people with BPD. All participants in this double-blind study will receive a psychiatric and medication evaluation prior to starting treatment. Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks. Psychological interviews and self-report questionnaires will be administered, taking approximately 5 to 10 hours to complete. Once all preliminary interviews and evaluations have been completed, each participant will be randomly assigned to one of the four following treatment groups:
All patients participating in this study will continue treatment for 12 months and will be evaluated bimonthly. After 12 months, participants will undergo neuropsychological testing to identify any changes that occurred over the last year. The clinical status of each participant will also be assessed at 18 and 24 months. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Decrease in suicidal ideation [ Time Frame: Assessed at 12, 18, and 24 months ] Decrease in suicide attempts [ Time Frame: Assessed at 12, 18, and 24 months ] Decrease in self-mutilation [ Time Frame: Assessed at 12, 18, and 24 months ] |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Borderline Personality Disorder | ||||||||
| Intervention † | Drug: Fluoxetine Behavioral: Dialectical behavior therapy Behavioral: Supportive psychotherapy |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 110 | ||||||||
| Start Date † | March 2001 | ||||||||
| Completion Date | December 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00533117 | ||||||||
| Organization ID | R01 MH61017 | ||||||||
| Secondary IDs †† | DSIR 83-ATP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | September 19, 2007 | ||||||||
| Last Updated Date | March 6, 2008 | ||||||||