Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001)
研究概览
简要总结
Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy as an antidissociative agent by using a double-blind randomized controlled trial.
详细描述
Patients were randomized into two groups starting with either 3 weeks of 50 mg/d naltrexone or with 3 weeks of placebo. In either case the active treatment phases (weeks 1-6) were followed by one week of placebo. The major purpose of weeks 1-2 and 4-5, respectively, was to achieve a steady state during the active treatment. The primary comparisons of psychopathology under naltrexone and placebo refer to the weeks following the intended achievement of a steady state (weeks 3 and 6, respectively).
6 weeks of treatment were split into two phases: (A) 3 weeks of pharmacologically active treatment with naltrexone and (B) 3 weeks of pharmacologically inactive treatment with placebo (cross-over design). The sequence of the two treatment phases was randomized and concealed from both the patients and the health care professionals. In both cases, the last week ("Week 7") was without pharmacological intervention.
The primary outcome was based on the DSS, a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) Mean scores for intensity (ranging from 0="no" to 9="very strong") and for duration (average time during which a particular symptom was present during the last 24 hours (in %)) were calculated for (a) dissociation (calculated from 21 Likert type items) and of (b) aversive inner tension (one item).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of BPD according to DSM-IV
- •DES score ≥ 18
- •Female gender
- •Age between 18 and 50 years
排除标准
- •Lifetime diagnosis of schizophrenia, psychotic or delusional disorder
- •Current major depressive episode
- •Lifetime diagnosis opioid dependence
- •Current diagnosis opioid abuse
- •Liver insufficiency or hepatitis
- •Other major medical or neurological medical condition
- •Pregnancy or lactation
- •Psychotropic medication within two weeks before and during the trial (fluoxetine 4 weeks, lithium 8 weeks)
- •Concomitant treatment with opioid analgetics
- •Hypersensitivity to naltrexone
研究组 & 干预措施
Naltrexone-Placebo
In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated.
干预措施: Naltrexone (Drug)
Naltrexone-Placebo
In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated.
干预措施: Placebo (Drug)
Placebo-Naltrexone
The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.
干预措施: Naltrexone (Drug)
Placebo-Naltrexone
The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.
干预措施: Placebo (Drug)
结局指标
主要结局
Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001)
时间窗: Oct. 1998-Oct 2001
次要结局
- The number, the method, and the severity of non-suicidal self-injurious acts during the last week.
- Number and intensity of flashbacks during the last week.