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

Primary Purpose

Borderline Personality Disorder, Suicide

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
DBT
Citalopram
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Suicidal and Self-Injurious Behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fluoxetine

Dialectical behavior therapy

Arm Description

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

Participants will receive dialectical behavioral therapy (DBT).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With 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.

Full Information

First Posted
February 2, 2009
Last Updated
July 20, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00834834
Brief Title
Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder
Official Title
Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Suicide
Keywords
Suicidal and Self-Injurious Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Active Comparator
Arm Description
Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.
Arm Title
Dialectical behavior therapy
Arm Type
Active Comparator
Arm Description
Participants will receive dialectical behavioral therapy (DBT).
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
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.
Intervention Type
Behavioral
Intervention Name(s)
DBT
Intervention Description
One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.
Primary Outcome Measure Information:
Title
Suicide Events
Description
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.
Time Frame
Measured after 6 months of treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Suicide Events
Description
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.
Time Frame
measured after 6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara H. Stanley, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived

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

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