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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: A
Dialectal behavior therapy and fluoxetine
|
Drug: Fluoxetine
Other Name: Prozac
Behavioral: Dialectical behavior therapy
|
|
Placebo Comparator: B
Dialectal behavior therapy and placebo
|
Behavioral: Dialectical behavior therapy |
|
Experimental: C
Supportive psychotherapy and fluoxetine
|
Drug: Fluoxetine
Other Name: Prozac
Behavioral: Supportive psychotherapy
|
|
Placebo Comparator: D
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00533117 History of Changes |
| Other Study ID Numbers: | R01 MH61017, DSIR 83-ATP |
| Study First Received: | September 19, 2007 |
| Last Updated: | March 6, 2008 |
| Health Authority: | United States: Federal Government |
|
suicide self-mutilation fluoxetine |
placebo dialectical behavior therapy supportive therapy |
|
Personality Disorders Borderline Personality Disorder Self Mutilation Mental Disorders 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 |