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Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2008
First Received: September 19, 2007   Last Updated: March 6, 2008   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00533117
  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 IV

MedlinePlus related topics: Personality Disorders Suicide
Drug Information available for: Fluoxetine Fluoxetine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: March 2001
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
A: Experimental
Dialectal behavior therapy and fluoxetine
Drug: Fluoxetine Behavioral: Dialectical behavior therapy
B: Placebo Comparator
Dialectal behavior therapy and placebo
Behavioral: Dialectical behavior therapy
C: Experimental
Supportive psychotherapy and fluoxetine
Drug: Fluoxetine Behavioral: Supportive psychotherapy
D: Placebo Comparator
Supportive psychotherapy and placebo
Behavioral: Supportive psychotherapy

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

Contacts
Contact: Barbara Stanley, PhD bhs2@columbia.edu
Contact: Shelly Groves, BA 212-543-6232 sgroves@neuron.cpmc.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Shelly Groves, BA     212-543-6232     sgroves@neuron.cpmc.columbia.edu    
Sub-Investigator: Beth Brodsky, PhD            
Sub-Investigator: Leo Sher, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Barbara Stanley, PhD Research Foundation for Mental Hygiene/Columbia University
  More Information

No publications provided

Study ID Numbers: R01 MH61017, DSIR 83-ATP
Study First Received: September 19, 2007
Last Updated: March 6, 2008
ClinicalTrials.gov Identifier: NCT00533117     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
suicide
self-mutilation
fluoxetine
placebo
dialectical behavior therapy
supportive therapy

Study placed in the following topic categories:
Neurotransmitter Agents
Psychotropic Drugs
Wounds and Injuries
Suicide
Disorders of Environmental Origin
Borderline Personality Disorder
Serotonin Uptake Inhibitors
Self Mutilation
Serotonin
Behavioral Symptoms
Fluoxetine
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Personality Disorders
Self-Injurious Behavior

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

ClinicalTrials.gov processed this record on May 07, 2009