Status:
COMPLETED
Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Borderline Personality Disorder
Suicide
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will compare the effectiveness of two treatments, dialectical behavior therapy versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal behavior in peop...
Detailed Description
Borderline personality disorder (BPD) is a chronic disorder in emotional regulation and is characterized by instability in self-image, mood, relationships, and behavior. People suffering from BPD have...
Eligibility Criteria
Inclusion
- Meets Diagnostic and Statistical Manual (DSM-IV) criteria for borderline personality disorder (BPD)
- Attempted suicide in the past 2 months
- At least one additional suicide attempt, suicide-related behavior, or self-injury episode in the past year
- Current suicidal ideation
- Able to be managed as an outpatient
- Not currently receiving optimum psychiatric treatment and agrees to notify study staff if any psychiatric care outside this study is sought. If care other than that permitted by the protocol is utilized, participants can no longer be enrolled in the study.
- Has a stable living arrangement at study entry
- Speaks English
- Willing and judged to be clinically able to undergo wash-out of psychotropic medications, except for occasional benzodiazepines use, for 2 to 6 weeks before treatment
- Females must be willing to use an effective method of birth control.
Exclusion
- Meets the DSM-IV criteria for mental retardation or the following disorders: bipolar I, schizophrenia, delusional disorder, schizophreniform disorder, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS)
- Needs priority treatment for acute medical illness or other debilitating problem, such as severe substance dependence or anorexia
- Pregnant
- Clinically too unstable to be maintained as an outpatient
- Has clearly failed adequate trials of fluoxetine and citalopram for a major depression in the past 2 years
- History of severe allergies, adverse drug reactions, or known allergy to fluoxetine or citalopram
- Clinically inadvisable for the participant to end current treatment
- Heart pacemaker body implant; other metal implants, such as shrapnel or surgical prostheses; or paramagnetic objects contained within the body, as assessed via a metal screening questionnaire, which may present a risk to the participant or interfere with the fMRI scan
- Diagnosed with Raynaud's disorder
- History of hypertension, cardiovascular disease, or abnormal electrocardiograms (EKGs)
- Claustrophobia or significant discomfort in enclosed space
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00834834
Start Date
March 1 2009
End Date
August 1 2015
Last Update
August 18 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032