Borderline Personality DisorderPhase 4NCT00834834
Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder
A Phase 4 study testing Fluoxetine, DBT and Citalopram in people with Borderline Personality Disorder and Suicide, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, Suicide
- What is being tested?
- Fluoxetine, DBT and Citalopram
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
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.
Read the 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
- Being tested
- Fluoxetine, DBT, Citalopram
- Keywords
- Suicidal and Self-Injurious Behavior
- Medical subject headings
- Borderline Personality Disorder, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
DBTBehavioural
One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
CitalopramDrug
Also called Celexa
Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Active comparator | Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Receives: Drug: Fluoxetine; Drug: Citalopram |
| Dialectical behavior therapy | Active comparator | Participants will receive dialectical behavioral therapy (DBT). Receives: Behavioral: DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured after 6 months of treatment
Secondary outcomes (1)
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.
Measured: measured after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Barbara H. Stanley, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834834
- Sponsor's protocol ID
- #5752/6777R
- Other IDs
- R01MH061017, R01MH061017-06A2
- Status last verified
- Jul 2017
- First submitted
- 2 Feb 2009
- Last updated
- 18 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
- ClinicalTrials.gov ID
- NCT00834834
- Acronym / sponsor ID
- #5752/6777R
- Conditions
- Borderline Personality Disorder, Suicide
- Keywords
- Suicidal and Self-Injurious Behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Active comparator | Drug: Fluoxetine, Drug: CitalopramParticipants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. |
| Dialectical behavior therapy | Active comparator | Behavioral: DBTParticipants will receive dialectical behavioral therapy (DBT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineAlso: ProzacStarting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. | Drug | Fluoxetine |
| DBTOne 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months. | Behavioural | Dialectical behavior therapy |
| CitalopramAlso: CelexaDose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months. | Drug | Fluoxetine |
Primary outcome
Suicide Events
Time frame: 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.
1 secondary outcome
Number of Participants With Suicide Events
Time frame: measured after 6 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara H. Stanley, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine, DBT and Citalopram in people with Borderline Personality Disorder and Suicide, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Events (time frame: Measured after 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.