Phase 4 N=75 Randomized Triple-blind Treatment

Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder

Borderline Personality Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00533117 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Aug 2017

Primary outcome: Primary: Suicide Attempts — 2; 1; 4; 1 suicide attempt

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Fluoxetine (Drug); Dialectical Behavior Therapy (Behavioral); Supportive psychotherapy (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Suicide Attempts	2; 1; 4; 1	—

Summary

This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.

Eligibility Criteria

Inclusion Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00533117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.