Borderline Personality DisorderPhase 4NCT00533117
Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
A Phase 4 study testing Fluoxetine, Dialectical Behavior Therapy and Supportive psychotherapy in people with Borderline Personality Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Fluoxetine, Dialectical Behavior Therapy and Supportive psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Dec 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for diagnosis of borderline personality disorder
- History of at least one suicide attempt or self-mutilation episode 12 months prior to study entry
- Experiences continued urges to self-mutilate or attempt suicide
- Stable living situation
- Use of effective birth control if sexually active
- Clinically stable enough to tolerate placebo condition
- Not participating in other forms of treatment during the study
Who cannot join
- Any current organic mental syndromes, lifetime schizophrenic or bipolar disorders, psychotic disorders, or mental retardation
- Inability to complete psychiatric interview due to lack of cooperation or lack of comprehension
- Unable to tolerate fluoxetine or DBT
- Currently receiving treatment for an acute medical illness or other debilitating problem, including substance abuse or anorexia nervosa
- History of major depression lasting more than 3 months
- Current Hamilton depression score above 22 and not receiving treatment
- Pregnant or breastfeeding
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
This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.
Read the detailed description
Borderline personality disorder (BPD) can be a serious and very complex condition. BPD affects 2% to 3% of the population and is more commonly diagnosed in young women. BPD is characterized by mood swings, impulsive behavior, difficulty controlling emotions, and acting out inappropriately either through self-harm or attempts of suicide. Other illnesses such as depression and anxiety are also very common in people diagnosed with BPD. Various treatments exist that aim to reduce self-harm and suicide among people with BPD. Dialectical behavior therapy (DBT), an outpatient behavioral therapy shown to help self-injurious patients with BPD, has become a popular treatment. Another useful treatment, the antidepressant fluoxetine, can help to regulate mood and diminish suicidal or self-destructive urges. Although combination treatments of DBT and fluoxetine are common, little research has been conducted on the effectiveness of this kind of combined treatment. The purpose of this study is to determine whether DBT and fluoxetine are more effective combined or alone in treating people with BPD.
All participants in this double-blind study will receive a psychiatric and medication evaluation prior to starting treatment. Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks. Psychological interviews and self-report questionnaires will be administered, taking approximately 5 to 10 hours to complete. Once all preliminary interviews and evaluations have been completed, each participant will be randomly assigned to one of the four following treatment groups:
- Group 1 will receive DBT and fluoxetine (Prozac). DBT teaches patients new skills to replace old coping strategies such as suicide attempts and self-injury. Participants will work with an individual therapist for 1 hour a week to learn these new skills. This group will also be expected to keep a weekly diary that will discuss their current mood; suicidal and self-harming urges; and possible use of medications, drugs, and alcohol. Once a week participants will engage in a 90-minute skills training group to review the skills learned during therapy. Homework will be assigned between sessions to review these new strategies and skills. Participants will meet regularly with a psychiatrist to receive fluoxetine, discuss any side effects, and adjust dosage if necessary.
- Group 2 participants will receive DBT and placebo medication.
- Group 3 participants will receive supportive therapy and fluoxetine. Supportive therapy is nondirective and focuses on strengths, coping abilities, and current areas of difficulty in life in an unstructured format. Participants in this group will meet with an individual therapist each week for 50 minutes. Patients will also be assigned to a psychiatrist to receive fluoxetine every other week.
- Group 4 participants will receive supportive psychotherapy and placebo medication.
All patients participating in this study will continue treatment for 12 months and will be evaluated bimonthly. After 12 months, participants will undergo neuropsychological testing to identify any changes that occurred over the last year. The clinical status of each participant will also be assessed at 18 and 24 months.
- Conditions
- Borderline Personality Disorder
- Being tested
- Fluoxetine, Dialectical Behavior Therapy, Supportive psychotherapy
- Keywords
- suicide, self-mutilation, fluoxetine, placebo, dialectical behavior therapy, supportive therapy
- 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
Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Dialectical Behavior TherapyBehavioural
Also called DBT
Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
Supportive psychotherapyBehavioural
Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy Fluoxetine | Experimental | Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy (CBT) targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, a selective serotonin reuptake inhibitor (SSRI) that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Receives: Drug: Fluoxetine; Behavioral: Dialectical Behavior Therapy |
| Dialectical Behavior Therapy placebo | Placebo comparator | Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Receives: Behavioral: Dialectical Behavior Therapy |
| Supportive therapy Fluoxetine | Experimental | Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. Receives: Drug: Fluoxetine; Behavioral: Supportive psychotherapy |
| Supportive therapy placebo | Active comparator | Supportive psychotherapy and placebo See above for descriptions. Receives: Behavioral: Supportive psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Attempts
Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Measured: Assessed bimonthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startMar 2001
- Primary completionJan 2008
- Study completionDec 2012
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 (2)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 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
- Principal investigator, Beth Brodsky, New York State Psychiatric Institute
- Investigators
- Barbara Stanley, PhD, Principal investigator, Research Foundation for Mental Hygiene/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533117
- Sponsor's protocol ID
- #5401R
- Other IDs
- R01MH061017-02
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2007
- Last updated
- 5 Jan 2024
- 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 33884617Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. 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
- ClinicalTrials.gov ID
- NCT00533117
- Acronym / sponsor ID
- #5401R
- Conditions
- Borderline Personality Disorder
- Keywords
- suicide, self-mutilation, fluoxetine, placebo, dialectical behavior therapy, supportive therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2001
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Posted 28 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 determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.
Detailed description
Borderline personality disorder (BPD) can be a serious and very complex condition. BPD affects 2% to 3% of the population and is more commonly diagnosed in young women. BPD is characterized by mood swings, impulsive behavior, difficulty controlling emotions, and acting out inappropriately either through self-harm or attempts of suicide. Other illnesses such as depression and anxiety are also very common in people diagnosed with BPD. Various treatments exist that aim to reduce self-harm and suicide among people with BPD. Dialectical behavior therapy (DBT), an outpatient behavioral therapy shown to help self-injurious patients with BPD, has become a popular treatment. Another useful treatment, the antidepressant fluoxetine, can help to regulate mood and diminish suicidal or self-destructive urges. Although combination treatments of DBT and fluoxetine are common, little research has been conducted on the effectiveness of this kind of combined treatment. The purpose of this study is to determine whether DBT and fluoxetine are more effective combined or alone in treating people with BPD.
All participants in this double-blind study will receive a psychiatric and medication evaluation prior to starting treatment. Participants taking psychiatric medications prior to the study will be slowly withdrawn from the medications over a period of 2 to 6 weeks. Psychological interviews and self-report questionnaires will be administered, taking approximately 5 to 10 hours to complete. Once all preliminary interviews and evaluations have been completed, each participant will be randomly assigned to one of the four following treatment groups:
- Group 1 will receive DBT and fluoxetine (Prozac). DBT teaches patients new skills to replace old coping strategies such as suicide attempts and self-injury. Participants will work with an individual therapist for 1 hour a week to learn these new skills. This group will also be expected to keep a weekly diary that will discuss their current mood; suicidal and self-harming urges; and possible use of medications, drugs, and alcohol. Once a week participants will engage in a 90-minute skills training group to review the skills learned during therapy. Homework will be assigned between sessions to review these new strategies and skills. Participants will meet regularly with a psychiatrist to receive fluoxetine, discuss any side effects, and adjust dosage if necessary.
- Group 2 participants will receive DBT and placebo medication.
- Group 3 participants will receive supportive therapy and fluoxetine. Supportive therapy is nondirective and focuses on strengths, coping abilities, and current areas of difficulty in life in an unstructured format. Participants in this group will meet with an individual therapist each week for 50 minutes. Patients will also be assigned to a psychiatrist to receive fluoxetine every other week.
- Group 4 participants will receive supportive psychotherapy and placebo medication.
All patients participating in this study will continue treatment for 12 months and will be evaluated bimonthly. After 12 months, participants will undergo neuropsychological testing to identify any changes that occurred over the last year. The clinical status of each participant will also be assessed at 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy Fluoxetine | Experimental | Drug: Fluoxetine, Behavioral: Dialectical Behavior TherapyDialectal behavior therapy (DBT) is a form of Cognitive behavior therapy (CBT) targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, a selective serotonin reuptake inhibitor (SSRI) that is given in standard dosing 20, 40, 60, 80 mg for 12 months. |
| Dialectical Behavior Therapy placebo | Placebo comparator | Behavioral: Dialectical Behavior TherapyDialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. |
| Supportive therapy Fluoxetine | Experimental | Drug: Fluoxetine, Behavioral: Supportive psychotherapySupportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months. |
| Supportive therapy placebo | Active comparator | Behavioral: Supportive psychotherapySupportive psychotherapy and placebo See above for descriptions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meets criteria for diagnosis of borderline personality disorder
- History of at least one suicide attempt or self-mutilation episode 12 months prior to study entry
- Experiences continued urges to self-mutilate or attempt suicide
- Stable living situation
- Use of effective birth control if sexually active
Key exclusion criteria (7 listed)
- Any current organic mental syndromes, lifetime schizophrenic or bipolar disorders, psychotic disorders, or mental retardation
- Inability to complete psychiatric interview due to lack of cooperation or lack of comprehension
- Unable to tolerate fluoxetine or DBT
- Currently receiving treatment for an acute medical illness or other debilitating problem, including substance abuse or anorexia nervosa
- History of major depression lasting more than 3 months
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: ProzacFluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated | Drug | Dialectical Behavior Therapy Fluoxetine, Supportive therapy Fluoxetine |
| Dialectical Behavior TherapyAlso: DBTDialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group. | Behavioural | Dialectical Behavior Therapy Fluoxetine, Dialectical Behavior Therapy placebo |
| Supportive psychotherapySupportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress. | Behavioural | Supportive therapy Fluoxetine, Supportive therapy placebo |
Primary outcome
Suicide Attempts
Time frame: Assessed bimonthly
Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.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 Stanley, PhD principal investigator
Research Foundation for Mental Hygiene/Columbia University
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, Dialectical Behavior Therapy and Supportive psychotherapy in people with Borderline Personality Disorder, 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 7 inclusion and 7 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 5 Jan 2024. 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. Some participants in this study may receive a placebo. 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 28 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 Attempts (time frame: Assessed bimonthly). 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 NCT00533117, which also lists 2 linked publications.
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 5 Jan 2024.