NCT00124839终止3 期
Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder
Central Institute of Mental Health, Mannheim5 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Reduction of dissociative symptoms
研究概览
简要总结
The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
- •DES-(Dissociative Experience Scale)-score: > or equal 18 according to amendment4 (former value according to amendment 2 was > or equal 25).
- •Urinary test of opiates negative
- •No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
- •No Lithium for two months
排除标准
- •Lifetime diagnosis of psychotic disorder
- •Current major depressive disorder (MDD)
- •Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
- •Comedication with opioid analgetics
- •Known naltrexone intolerance
- •Liver disease
- •Pregnancy and lactation period
- •Other severe medical or neurological diseases
- •Simultaneous participation in another study
研究组 & 干预措施
1
Other
Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week)
干预措施: Naltrexone (Drug)
2
Other
Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week)
干预措施: Naltrexone (Drug)
3
Other
Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week)
干预措施: Naltrexone (Drug)
4
Other
Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week)
干预措施: Naltrexone (Drug)
结局指标
主要结局
Reduction of dissociative symptoms
时间窗: End of 3rd week treatment of naltrexon
次要结局
- Reduction of flashbacks(End of 3rd week treatment of naltrexone)
- Reduction of self-injurious behavior(End of 3rd week treatment of naltrexone)
- Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)(End of 3rd week treatment of naltrexone)
- Safety regarding liver enzyme elevation(End of 3rd week treatment of naltrexone)
研究者
研究点 (5)
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