SSRIs and Self-harm in Borderline Personality Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Self-harm Ideation
研究概览
简要总结
The goal of this study is to examine the effectiveness the selective serotonin reuptake inhibitor (SSRI) escitalopram (also known by the trade name "Lexapro") in reducing desire to self-harm and actual self-harming among young adults with borderline personality disorder who are also currently depressed. Subjects will receive either escitalopram or placebo for eight weeks. During this time subjects will be make weekly visits to see the psychiatrist and record their thoughts and feelings several times each day using an electronic diary.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Borderline Personality Disorder
- •Current Major Depression
排除标准
- •Past 2 months SSRI use
- •Past 6 months non-SSRI antidepressant use
- •Past 2 months initiation of psychotherapy
- •Lifetime bipolar disorder, organic disorder, psychotic disorder
- •Current alcohol or drug dependence
- •Current severe suicidal / homicidal ideation necessitating immediate medical intervention
- •Currently pregnancy or nursing
- •Unable or unwilling to cooperate with study protocol
研究组 & 干预措施
Escitalopram
10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
干预措施: Escitalopram (Drug)
Placebo
Inert placebo (sugar pill) taken daily for eight weeks
干预措施: Escitalopram (Drug)
结局指标
主要结局
Self-harm Ideation
时间窗: pre-treatment (week 0) to post-treatment (end of week 8)
Self-harm ideation was measured by electronic diaries (EMA) up to four times a day. Each time a person completed an EMA diary they were asked to rate their urge to hurt themselves on a 5 point scale ( 0 to 4) pad where 0 is not at all, 2 is moderately and 4 is extremely strong.
次要结局
- Depressive Symptoms(baseline (week 0) and post treatment (week 8).)