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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00834834
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 77
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder; Suicide	Drug: Fluoxetine; Behavioral: DBT; Drug: Citalopram	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fluoxetine Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.	Drug: Fluoxetine; Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.; Other Names: Prozac ; Drug: Citalopram; Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.; Other Names: Celexa
Active Comparator: Dialectical behavior therapy Participants will receive dialectical behavioral therapy (DBT).	Behavioral: DBT; One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.

Outcome Measures

Primary Outcome Measures

1. Suicide Events [Measured after 6 months of treatment]

   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

1. Number of Participants With Suicide Events [measured after 6 months of treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Barbara H. Stanley, PhD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00834834
• Other Study ID Numbers: #5752/6777R; R01MH061017; R01MH061017-06A2
• First Posted: Feb 3, 2009
• Last Update Posted: Aug 18, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by New York State Psychiatric Institute: Suicidal and Self-Injurious Behavior
• Additional relevant MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder; Fluoxetine; Citalopram

Study Results

Participant Flow

Recruitment Details	Recruitment is from community clinicians, advertising and the emergency department.
Pre-assignment Detail	All participants are washed out of psychotropic medications. Benzodiazapines are permitted for sleep.

Arm/Group Title	Fluoxetine	Dialectical Behavior Therapy
Arm/Group Description	Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Period Title: Overall Study
STARTED	42	42
COMPLETED	38	39
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Fluoxetine	Dialectical Behavior Therapy	Total
Arm/Group Description	Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.	Total of all reporting groups
Overall Participants	42	42	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.9 (7.8)	30.6 (10.8)	29.3 (9.4)
Sex: Female, Male (Count of Participants)
Female	37 88.1%	40 95.2%	77 91.7%
Male	5 11.9%	2 4.8%	7 8.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 21.4%	11 26.2%	20 23.8%
Not Hispanic or Latino	33 78.6%	31 73.8%	64 76.2%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Dialectical Behavior Therapy
Arm/Group Description	Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Measure Participants	38	39
Number [suicide events]	12	4

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine	Dialectical Behavior Therapy
Arm/Group Description	Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Measure Participants	38	39
Number [participants]	6 14.3%	4 9.5%

Adverse Events

Time Frame	During 6 month treatment trial and 1 year follow up period.
Arm/Group Title	Fluoxetine		Dialectical Behavior Therapy
Arm/Group Description	Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.		Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
All Cause Mortality
	Fluoxetine		Dialectical Behavior Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluoxetine		Dialectical Behavior Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/38 (36.8%)		5/39 (12.8%)
Psychiatric disorders
Serious Adverse Event	14/38 (36.8%)	15	5/39 (12.8%)	8
Other (Not Including Serious) Adverse Events
	Fluoxetine		Dialectical Behavior Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.