Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Changes in score of Affective Lability Scale
研究概览
简要总结
This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability
排除标准
- •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
研究组 & 干预措施
1
干预措施: Lamotrigine (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in score of Affective Lability Scale
时间窗: 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
时间窗: Baseline and then weekly for 12 weeks
次要结局
- Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder(Baseline and then weekly for 12 weeks)