Overview

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

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Citalopram
Dexetimide
Fluoxetine
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