Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder
Condition: Borderline Personality Disorder; Suicide
MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder
Intervention: Fluoxetine; DBT; Citalopram
Intervention description: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.; One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.; Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.
Intervention MeSH terms: Fluoxetine; Citalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Suicidal and Self-Injurious Behavior

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 people with borderline personality disorder.
    

Eligibility criteria:

        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