Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Global Improvement Scale
研究概览
简要总结
Personality disorders are life-long maladaptive behavioral patterns. Borderline personality disorder (BPD) is the leading personality disorder encountered in clinical settings, often associated with tremendous distress. It is characterized by impulsivity, emotional lability, unstable interpersonal relationships, with particular sensitivity to abandonment. BPD patients are prone to self destructive behaviors and all too frequently attempt suicide. When in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.
Psychotherapy for BPD is a common treatment option, but it requires considerable time and specific personnel training, and is therefore not always feasible. Medical treatment is an efficacious alternative, however there is no concensus on drug selection. Some experts have suggested that medical treatment should be selected individually according to the subject's dominant clinical symptom. Several psychopharmacological groups have been proposed: Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are particularly promising since they may produce symptomaic improvement with fewer adverse effects. Risperidone has been shown in a few preliminary studies to be promising in the treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design using both clinical and phsysiological measure.The main hypothesis is that risperidone will be efficient in alleviating BPD core and secondary symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with Borderline PD according to DSM-IV
- •Signed informed consent.
排除标准
- •Psychotic disorders (past or present).
- •Substance or alcohol related disorders (past or present).
- •Current major depressive episode.
- •Suicidal risk.
- •History of head trauma, which caused loss of consciousness or peritraumatic amnesia or necessitated hospitalization.
- •Any known psychiatric or general medical condition currently requiring specific medical attention.
- •Current treatment with any antipsychotic, antidepressant drugs or mood stabilizers.
研究组 & 干预措施
2
干预措施: Risperidone (Drug)
1
干预措施: Risperidone (Drug)
结局指标
主要结局
Clinical Global Improvement Scale
时间窗: 0, 1, 5, 10 week
次要结局
未报告次要终点
