Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acamprosate would be efficacious for SSRI resistant OCD symptoms
研究概览
简要总结
This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.
详细描述
A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 19-55 years of age
- •have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
- •SSRI resistant patients with OCD
- •Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
- •Signed written informed consent prior to entering any study procedures.
- •Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit
排除标准
- •Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
- •Patients with concurrent DSM-IV diagnosis of mental retardation
- •Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
- •Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
- •Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
- •Patients with score of less than 16 on Y-BCOS during screening.
- •Patients with history of intolerance or hypersensitivity to acamprosate.
- •Patients based on history or mental status exam have significant risk fo committing suicide.
- •Patients who are homicidal or violent.
- •Patients with severe renal impairment
- •Female patients who are pregnant or lactating
- •Subjects with history of psychosurgery for OCD
结局指标
主要结局
Acamprosate would be efficacious for SSRI resistant OCD symptoms
时间窗: Patients will be administered 12 weeks of Acamprosate.
次要结局
- Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.(Patients will be administered 12 weeks of Acamprosate)