NCT00796497已完成4 期
Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study
Institute of Neuroscience, Florence, Italy1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and antipsychotics.
详细描述
METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for 6 weeks, that will be titrated to 0.5 mg twice daily for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18 to 55
- •a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 20 after ≥ 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after ≥ 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day)
排除标准
- •a history of alcohol or substance abuse
- •current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
- •heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
- •hoarding as only Obsessive Compulsive symptom
- •women of childbearing potential not using a medically acceptable contraceptive method.
研究组 & 干预措施
ondansetron
Experimental
干预措施: ondansetron (Drug)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: 6th 12th week
次要结局
- clinical global impression (CGI)(6th e 12th)
研究者
研究点 (1)
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