Clinical Trial: Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Detailed Summary:

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 Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks.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:

• Group 1 will receive DBT and fluoxetine (Prozac). DBT teaches patients new skills to replace old coping strategies such as suicide attempts and self-injury. Participants w
  Sponsor: New York State Psychiatric Institute
  

  Current Primary Outcome: Decrease in self injury (suicide-related behavior and NSSI) [ Time Frame: Assessed bimonthly and followup 6 and 12 months ]
  
  

  Original Primary Outcome:

  • Decrease in suicidal ideation [ Time Frame: Assesed 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 ]
  
  
  

  Current Secondary Outcome: suicide ideation, depression and impulsivity [ Time Frame: bimonthly and 6 and 12 months follow up ]
  
  

  Original Secondary Outcome:
  
  Information By: New York State Psychiatric Institute
  

  Dates:
  Date Received: September 19, 2007
  Date Started: March 2001
  Date Completion:
  Last Updated: September 25, 2013
  Last Verified: September 2013