Phase 4
Completed N=84
Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder
Source: ClinicalTrials.gov NCT00834834 ↗Enrolled (actual)
84
Serious AEs
24.7%
Results posted
Aug 2017
Primary outcomePrimary: Suicide Events — 12; 4 suicide events
◆ Published Evidence
Highly cited
122citations · ~24 / year
Psychosocial interventions for self-harm in adults.
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.
Linked Publications
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Psychosocial interventions for self-harm in adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suicide Events |
12; 4 | — |
| SECONDARY Number of Participants With Suicide Events |
6; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00834834) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.