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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00533117 |
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 |
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 |
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 |
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:
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara Stanley, PhD | bhs2@columbia.edu | |
Contact: Shelly Groves, BA | 212-543-6232 | sgroves@neuron.cpmc.columbia.edu |
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 |
Principal Investigator: | Barbara Stanley, PhD | Research Foundation for Mental Hygiene/Columbia University |
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 |
suicide self-mutilation fluoxetine |
placebo dialectical behavior therapy supportive therapy |
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 |
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 |