Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
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ClinicalTrials.gov Identifier: NCT00634062 |
Recruitment Status :
Completed
First Posted : March 12, 2008
Last Update Posted : March 12, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Borderline Personality Disorder | Drug: Lamotrigine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: Lamotrigine
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
Other Name: Lamictal |
Placebo Comparator: 2 |
Drug: Placebo
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. |
- 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 ]
- Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Baseline and then weekly for 12 weeks ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634062
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 |
Principal Investigator: | D. Bradford Reich, M.D. | Mclean Hospital |
Responsible Party: | D. Bradford Reich, M.D., McLean Hospital |
ClinicalTrials.gov Identifier: | NCT00634062 |
Other Study ID Numbers: |
2004-P-002640 |
First Posted: | March 12, 2008 Key Record Dates |
Last Update Posted: | March 12, 2008 |
Last Verified: | March 2008 |
Affective Lability Borderline Personality Disorder Pharmacotherapy |
Lamotrigine Disease Personality Disorders Borderline Personality Disorder Pathologic Processes Mental Disorders Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |