New York State Psychiatric Institute
New York, 10032, United States
NCT Number: NCT00533117
This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 4
New York, 10032, United States
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 Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Other names: Prozac
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 names: DBT
Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
Time frame: Assessed bimonthly
Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
New York State Psychiatric Institute
Other
Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06406972
Behavior, Behavioral Symptoms
Lund, Skåne County, Sweden
View Trial DetailsNCT02387736
Behavior, Behavioral Symptoms
Burnaby, British Columbia, Canada
View Trial DetailsNCT04779099
Behavior, Behavioral Symptoms
Toronto, Ontario, Canada
View Trial DetailsNCT00834834
Behavior, Behavioral Symptoms
New York, United States
View Trial Details