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

NCT00834834 | Completed Phase 4 Results DMC

• 3 other identifiers: #5752/6777RR01MH061017R01MH061017-06A2
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder; Suicide

Keywords

Suicidal and Self-Injurious Behavior

Outcome Measures

Primary Outcomes (1)

• Suicide Events

  Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual's actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.

  Measured after 6 months of treatment

Secondary Outcomes (1)

• Number of Participants With Suicide Events

  measured after 6 months of treatment

Study Arms (2)

Fluoxetine

ACTIVE COMPARATOR

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

Drug: Fluoxetine; Drug: Citalopram

Dialectical behavior therapy

ACTIVE COMPARATOR

Participants will receive dialectical behavioral therapy (DBT).

Behavioral: DBT

Interventions

Fluoxetine DRUG

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

Also known as: Prozac

Fluoxetine

DBT BEHAVIORAL

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

Dialectical behavior therapy

Citalopram DRUG

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

Also known as: Celexa

Fluoxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Suicide; Self-Injurious Behavior

Interventions

Fluoxetine; Citalopram

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Barbara Stanley, Ph.D.
• Organization: NYSPI

stanley@nyspi.columbia.edu

6467747582

Study Officials

• Barbara H. Stanley, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 18, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)