Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
2 other identifiers
interventional
91
1 country
1
Brief Summary
This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2001
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 28, 2017
CompletedJanuary 5, 2024
January 1, 2024
6.8 years
September 19, 2007
October 6, 2016
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Suicide Attempts
Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Assessed bimonthly
Study Arms (4)
Dialectical Behavior Therapy Fluoxetine
EXPERIMENTALDialectal behavior therapy (DBT) is a form of Cognitive behavior therapy (CBT) targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, a selective serotonin reuptake inhibitor (SSRI) that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Dialectical Behavior Therapy placebo
PLACEBO COMPARATORDialectal 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.
Supportive therapy Fluoxetine
EXPERIMENTALSupportive 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.
Supportive therapy placebo
ACTIVE COMPARATORSupportive psychotherapy and placebo See above for descriptions.
Interventions
Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
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.
Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
Eligibility Criteria
You may qualify if:
- Meets criteria for 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (2)
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PMID: 33884617DERIVEDStorebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PMID: 32368793DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara Stanley
- Organization
- NYSPI
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Stanley, PhD
Research Foundation for Mental Hygiene/Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 21, 2007
Study Start
March 1, 2001
Primary Completion
January 1, 2008
Study Completion
December 1, 2012
Last Updated
January 5, 2024
Results First Posted
August 28, 2017
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share