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

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 a high rate of self-injury and suicide attempts. This study will
compare the effectiveness of two treatments for preventing self-injury and suicide in people
with BPD: dialectical behavior therapy (DBT) and fluoxetine with clinical management. DBT is
a behavioral therapy that teaches new coping skills to replace old strategies, including
self-injury and attempted suicide. Fluoxetine is a selective serotonin reuptake inhibitor
(SSRI) medication that has been used to treat BPD. Clinical management of fluoxetine, which
is involved in administering the medication under normal conditions, refers to regular
visits with a psychiatrist who will monitor medication effectiveness and side effects.
Clinical management in this study may include adjusting the dosage of fluoxetine or
prescribing a change in medication to citalopram, another SSRI.

Participation in this study will last 12 months, including all follow-up assessments. During
the first study visit, participants will undergo baseline testing and be randomly assigned
to receive either DBT or fluoxetine with clinical management. After a washout period, in
which participants will transition off any medications they are currently taking,
participants will receive 6 months of their assigned treatment. Participants receiving DBT
will attend one 60-minute individual therapy session and one 90-minute group session every
week. Participants assigned to the fluoxetine with clinical management condition will begin
receiving 20 mg of fluoxetine daily and have their dose increased over the course of 4
weeks, based on tolerance, up to 40 mg. Participants assigned to fluoxetine may also be
switched to citalopram, if the study psychiatrist thinks it will be more effective.
Participants assigned to either fluoxetine or citalopram will undergo monthly blood tests to
monitor the level of medication in their bodies.

Every 2 weeks, participants will undergo assessments of treatment effectiveness and side
effects. After 2, 4, 6, 9, and 12 months, participants will undergo various
neuropsychological tests and clinical interviews and self-report questionnaires about mood
and life experiences. At study entry and at Weeks 12 and 24, participants will use a
handheld computer to complete a week-long assessment of emotions. Fully healthy female
participants will be asked to complete a functional magnetic resonance imaging (fMRI) scan,
which will assess their ability to regulate emotions at the neural level. The fMRI scan and
a stress test (for both men and women) will be performed at baseline and after 6 months.

Inclusion Criteria:

- Meets 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 benzodiazepine 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