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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00533117
First received: September 19, 2007
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Condition Intervention Phase
Borderline Personality Disorder
Drug: Fluoxetine
Behavioral: Dialectical Behavior Therapy
Behavioral: Supportive psychotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Decrease in self injury (suicide-related behavior and NSSI) [ Time Frame: Assessed bimonthly and followup 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • suicide ideation, depression and impulsivity [ Time Frame: bimonthly and 6 and 12 months follow up ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: March 2001
Study Completion Date: December 2012
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Drug: Fluoxetine
Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Other Name: Prozac
Behavioral: Dialectical Behavior Therapy
Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
Other Name: DBT
Placebo Comparator: B
Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Behavioral: Dialectical Behavior Therapy
Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
Other Name: DBT
Experimental: C
Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Drug: Fluoxetine
Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Other Name: Prozac
Behavioral: Supportive psychotherapy
Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
Active Comparator: D
Supportive psychotherapy and placebo See above for descriptions.
Behavioral: Supportive psychotherapy
Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.

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:

  • 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 will work with an individual therapist for 1 hour a week to learn these new skills. This group will also be expected to keep a weekly diary that will discuss their current mood; suicidal and self-harming urges; and possible use of medications, drugs, and alcohol. Once a week participants will engage in a 90-minute skills training group to review the skills learned during therapy. Homework will be assigned between sessions to review these new strategies and skills. Participants will meet regularly with a psychiatrist to receive fluoxetine, discuss any side effects, and adjust dosage if necessary.
  • Group 2 participants will receive DBT and placebo medication.
  • Group 3 participants will receive supportive therapy and fluoxetine. Supportive therapy is nondirective and focuses on strengths, coping abilities, and current areas of difficulty in life in an unstructured format. Participants in this group will meet with an individual therapist each week for 50 minutes. Patients will also be assigned to a psychiatrist to receive fluoxetine every other week.
  • Group 4 participants will receive supportive psychotherapy and placebo medication.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for DSM-IV diagnosis of borderline personality disorder
  • History of at least one suicide attempt or self-mutilation episode 12 months prior to study entry
  • Experiences continued urges to self-mutilate or attempt suicide
  • Stable living situation
  • Use of effective birth control if sexually active
  • Clinically stable enough to tolerate placebo condition
  • Not participating in other forms of treatment during the study

Exclusion Criteria:

  • Any current organic mental syndromes, lifetime schizophrenic or bipolar disorders, psychotic disorders, or mental retardation
  • Inability to complete psychiatric interview due to lack of cooperation or lack of comprehension
  • Unable to tolerate fluoxetine or DBT
  • Currently receiving treatment for an acute medical illness or other debilitating problem, including substance abuse or anorexia nervosa
  • History of major depression lasting more than 3 months
  • Current Hamilton depression score above 22 and not receiving treatment
  • Pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533117

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Barbara Stanley, PhD Research Foundation for Mental Hygiene/Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00533117     History of Changes
Other Study ID Numbers: #5401R, R01MH061017-02
Study First Received: September 19, 2007
Last Updated: September 25, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
suicide
self-mutilation
fluoxetine
placebo
dialectical behavior therapy
supportive therapy

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Disease
Self Mutilation
Mental Disorders
Pathologic Processes
Wounds and Injuries
Self-Injurious Behavior
Behavioral Symptoms
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014