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Borderline Personality Disorder | Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder

Borderline Personality Disorder research study

What is the primary objective of this study?

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 people with borderline personality disorder.

Who is eligible to participate?

Inclusion Criteria: - 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 Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Borderline Personality Disorder

Suicide

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FluoxetineStarting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.

Behavioral:DBTOne 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.

Drug:CitalopramDose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

FluoxetineParticipants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.

Dialectical behavior therapyParticipants will receive dialectical behavioral therapy (DBT).

Study Status

Completed

Start Date: March 2009

Completed Date: August 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Suicide Events

Secondary Outcome: Number of Participants With Suicide Events

Study sponsors, principal investigator, and references

Principal Investigator: Barbara H. Stanley, PhD

Lead Sponsor: New York State Psychiatric Institute

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT00834834

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