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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00834834

Purpose

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	Intervention	Phase
Borderline Personality Disorder Suicide	Drug: Fluoxetine Behavioral: DBT Drug: Citalopram	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders Suicide

Drug Information available for: Benzetimide Dexetimide Fluoxetine Fluoxetine hydrochloride Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Suicidal and self-injurious behavior [ Time Frame: Measured after 6 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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 Name: Prozac Drug: Citalopram Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months. Other Name: Celexa
Active Comparator: 2 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets 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 benzodiazepine 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834834

Contacts

Contact: Barbara H. Stanley, PhD

212-543-5918

bhs2@columbia.edu

Locations

United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Contact: Barbara H. Stanley, PhD 212-543-5918 bhs2@columbia.edu

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Barbara H. Stanley, PhD

New York State Psychiatric Institute

More Information

No publications provided

Responsible Party:	Barbara H. Stanley, PhD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00834834 History of Changes
Other Study ID Numbers:	R01 MH061017, R01-MH061017-06A2, DSIR 83-ATP
Study First Received:	February 2, 2009
Last Updated:	April 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Suicidal and Self-Injurious Behavior

Additional relevant MeSH terms:

Personality Disorders
Borderline Personality Disorder
Suicide
Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms
Citalopram
Fluoxetine
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012