Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder
Condition: Borderline Personality Disorder; Suicide
MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the effectiveness of two treatments, dialectical behavior therapy
      versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal
      behavior in people with borderline personality disorder.
    

Detailed description: 
      Borderline personality disorder (BPD) is a chronic disorder in emotional regulation and is
      characterized by instability in self-image, mood, relationships, and behavior. People
      suffering from BPD have a high rate of self-injury and suicide attempts. This study will
      compare the effectiveness of two treatments for preventing self-injury and suicide in people
      with BPD: dialectical behavior therapy (DBT) and fluoxetine with clinical management. DBT is
      a behavioral therapy that teaches new coping skills to replace old strategies, including
      self-injury and attempted suicide. Fluoxetine is a selective serotonin reuptake inhibitor
      (SSRI) medication that has been used to treat BPD. Clinical management of fluoxetine, which
      is involved in administering the medication under normal conditions, refers to regular visits
      with a psychiatrist who will monitor medication effectiveness and side effects. Clinical
      management in this study may include adjusting the dosage of fluoxetine or prescribing a
      change in medication to citalopram, another SSRI.

      Participation in this study will last 12 months, including all follow-up assessments. During
      the first study visit, participants will undergo baseline testing and be randomly assigned to
      receive either DBT or fluoxetine with clinical management. After a washout period, in which
      participants will transition off any medications they are currently taking, participants will
      receive 6 months of their assigned treatment. Participants receiving DBT will attend one
      60-minute individual therapy session and one 90-minute group session every week. Participants
      assigned to the fluoxetine with clinical management condition will begin receiving 20 mg of
      fluoxetine daily and have their dose increased over the course of 4 weeks, based on
      tolerance, up to 40 mg. Participants assigned to fluoxetine may also be switched to
      citalopram, if the study psychiatrist thinks it will be more effective. Participants assigned
      to either fluoxetine or citalopram will undergo monthly blood tests to monitor the level of
      medication in their bodies.

      Every 2 weeks, participants will undergo assessments of treatment effectiveness and side
      effects. After 2, 4, 6, 9, and 12 months, participants will undergo various
      neuropsychological tests and clinical interviews and self-report questionnaires about mood
      and life experiences. At study entry and at Weeks 12 and 24, participants will use a handheld
      computer to complete a week-long assessment of emotions. Fully healthy female participants
      will be asked to complete a functional magnetic resonance imaging (fMRI) scan, which will
      assess their ability to regulate emotions at the neural level. The fMRI scan and a stress
      test (for both men and women) will be performed at baseline and after 6 months.
    

Intervention name(s): Fluoxetine; DBT; Citalopram
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.; One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.; Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.
Other intervention name(s): Prozac; Celexa
Intervention MeSH terms: Fluoxetine; Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Suicidal and Self-Injurious Behavior