Clinical Trial: Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change

Brief 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 Summary:

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 think
Sponsor: New York State Psychiatric Institute

Current Primary Outcome: Suicidal and self-injurious behavior [ Time Frame: Measured after 6 months of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York State Psychiatric Institute

Dates:
Date Received: February 2, 2009
Date Started: March 2009
Date Completion: August 2015
Last Updated: September 25, 2013
Last Verified: September 2013