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

NCT ID: NCT00834834

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Borderline Personality Disorder; Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fluoxetine

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

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: 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.

Citalopram

Intervention Type: DRUG

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

Dialectical behavior therapy

Participants will receive dialectical behavioral therapy (DBT).

Group Type: ACTIVE_COMPARATOR

DBT

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DRUG

DBT

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

Intervention Type: BEHAVIORAL

Citalopram

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

Intervention Type: DRUG

Other Intervention Names

Prozac; Celexa

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara H. Stanley, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

Other Identifiers

R01MH061017

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH061017-06A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#5752/6777R

Identifier Type: -

Identifier Source: org_study_id