Borderline Personality DisorderPhase 4NCT00634062
Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
A Phase 4 study testing Lamotrigine in people with Borderline Personality Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability
Who cannot join
- Clinical diagnosis of Bipolar Disorder
- Clinical diagnosis of psychiatric disorder related to general medical condition
- Clinical diagnosis of substance abuse disorder within the last 60 days
- Clinical diagnosis of psychotic disorder
- Previous treatment with lamotrigine
- Pregnancy or nursing
- Currently hospitalized
- Active suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.
Read the detailed description
Affective instability is one of the most prominent symptoms in borderline personality disorder. Currently there are no prospective studies of treatment of this symptom with mood stabilizing medications. This study examines the effectiveness of lamotrigine compared to placebo in reducing emotional instability of several types in borderline patients. The types of emotional instability studied involve anger, anxiety, depression, and elation. Subjects entering this 12 week study will be blind to whether they are receiving active medication or placebo. They will be asked to report levels of instability in their mood on a weekly basis. They will also be asked weekly to rate the intensity of other symptoms of borderline personality disorder symptoms, such as unstable relationships, self-harm, and impulsive behaviors.
- Conditions
- Borderline Personality Disorder
- Being tested
- Lamotrigine, Placebo
- Keywords
- Affective Lability, Borderline Personality Disorder, Pharmacotherapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Also called Lamictal
Subject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks
PlaceboDrug
Subjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Lamotrigine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score of Affective Lability Scale
Measured: Baseline and then weekly for 12 weeks
Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder
Measured: Baseline and then weekly for 12 weeks
Secondary outcomes (1)
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder
Measured: Baseline and then weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startDec 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- D. Bradford Reich, M.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634062
- Sponsor's protocol ID
- 2004-P-002640
- Status last verified
- Mar 2008
- First submitted
- 4 Mar 2008
- Last updated
- 12 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weinstein W, Jamison KL. Retrospective case review of lamotrigine use for affective instability of borderline personality disorder. CNS Spectr. 2007 Mar;12(3):207-10. doi: 10.1017/s1092852900020927.
PubMed 17329981Tritt K, Nickel C, Lahmann C, Leiberich PK, Rother WK, Loew TH, Nickel MK. Lamotrigine treatment of aggression in female borderline-patients: a randomized, double-blind, placebo-controlled study. J Psychopharmacol. 2005 May;19(3):287-91. doi: 10.1177/0269881105051540.
PubMed 15888514Pinto OC, Akiskal HS. Lamotrigine as a promising approach to borderline personality: an open case series without concurrent DSM-IV major mood disorder. J Affect Disord. 1998 Dec;51(3):333-43. doi: 10.1016/s0165-0327(99)00007-5.
PubMed 10333987Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
PubMed 36375174
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT00634062
- Acronym / sponsor ID
- 2004-P-002640
- Conditions
- Borderline Personality Disorder
- Keywords
- Affective Lability, Borderline Personality Disorder, Pharmacotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.
Detailed description
Affective instability is one of the most prominent symptoms in borderline personality disorder. Currently there are no prospective studies of treatment of this symptom with mood stabilizing medications. This study examines the effectiveness of lamotrigine compared to placebo in reducing emotional instability of several types in borderline patients. The types of emotional instability studied involve anger, anxiety, depression, and elation. Subjects entering this 12 week study will be blind to whether they are receiving active medication or placebo. They will be asked to report levels of instability in their mood on a weekly basis. They will also be asked weekly to rate the intensity of other symptoms of borderline personality disorder symptoms, such as unstable relationships, self-harm, and impulsive behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lamotrigine |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability
Key exclusion criteria (8 listed)
- Clinical diagnosis of Bipolar Disorder
- Clinical diagnosis of psychiatric disorder related to general medical condition
- Clinical diagnosis of substance abuse disorder within the last 60 days
- Clinical diagnosis of psychotic disorder
- Previous treatment with lamotrigine
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 |
|---|---|---|
| LamotrigineAlso: LamictalSubject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks | Drug | 1 |
| PlaceboSubjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo. | Drug | 2 |
Primary outcome
Changes in score of Affective Lability Scale
Time frame: Baseline and then weekly for 12 weeks
Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder
Time frame: Baseline and then weekly for 12 weeks
1 secondary outcome
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder
Time frame: Baseline and then weekly for 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2008.
- Background: PubMed 17329981Weinstein W, Jamison KL. Retrospective case review of lamotrigine use for affective instability of borderline personality disorder. CNS Spectr. 2007 Mar;12(3):207-10. doi: 10.1017/s1092852900020927.
- Background: PubMed 15888514Tritt K, Nickel C, Lahmann C, Leiberich PK, Rother WK, Loew TH, Nickel MK. Lamotrigine treatment of aggression in female borderline-patients: a randomized, double-blind, placebo-controlled study. J Psychopharmacol. 2005 May;19(3):287-91. doi: 10.1177/0269881105051540.
- Background: PubMed 10333987Pinto OC, Akiskal HS. Lamotrigine as a promising approach to borderline personality: an open case series without concurrent DSM-IV major mood disorder. J Affect Disord. 1998 Dec;51(3):333-43. doi: 10.1016/s0165-0327(99)00007-5.
- Derived from this study: PubMed 36375174Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
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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.
D. Bradford Reich, M.D. principal investigator
Mclean Hospital
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 Lamotrigine in people with Borderline Personality Disorder, run by Mclean Hospital 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 1 inclusion and 8 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 12 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in score of Affective Lability Scale (time frame: Baseline and then weekly for 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00634062, which also lists 4 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 12 Mar 2008.