Ondansetron Augmentation in Treatment-resistant OCD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale
研究概览
简要总结
The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of OCD established by clinical interview with a licensed psychiatrist;
- •a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale
- •a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose
排除标准
- •diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder
- •undergoing concomitant behavior therapy
- •or having significant cardiovascular, hepatic, renal or pulmonary diseases
研究组 & 干预措施
obsessive compulsive disorder
obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly
干预措施: Ondansetron (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale
时间窗: week 16
次要结局
- The Drug Effect scale(week 16)