Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The change in Yale Brown obsessive compulsive scale (Y-BOCS) from baseline to week 10 and the number of responders are the primary efficacy parameters.
研究概览
简要总结
Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at least three previous treatments with a SRI at maximum dose and duration were assigned to receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is postulated that the combination of a low dose atypical antipsychotic and a standard dosage of an SRI as a treatment for patients with OCD might increase the number of responders as well as the effect size.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients meet the DSM IV criteria for obsessive-compulsive disorder
- •Y-BOCS score > 16 if obsessions and compulsions
- •Y-BOCS score > 10 if only obsessions
- •Y-BOCS score > 10 if only compulsions
- •Male and female, aged between 18-70 years
- •Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception.
- •Written informed consent
排除标准
- •Presence of any of the following DSM IV conditions; major depression (with a HDRS>15, [17 item]), bipolar disorder, schizophrenia or any other psychotic condition, tic disorder, substance related disorder during the past 6 months, epilepsy, or any structural CNS disorder or stroke within the last year.
- •Evidence of clinically significant and unstable cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year, or micturition abnormalities
- •Patients at risk for suicide
- •Multiple serious drug allergies or known allergy for the trial compounds
- •Use of antipsychotics during 6 months before the screening visit
- •Use of any other psychotropic drug during 6 months before the screening visit
- •Cognitive and behavioural treatment 3 months prior to the screening visit
- •Any known contra-indication against citalopram or quetiapine
结局指标
主要结局
The change in Yale Brown obsessive compulsive scale (Y-BOCS) from baseline to week 10 and the number of responders are the primary efficacy parameters.
Criteria for response will be a 25% or greater change from baseline on the Y-BOCS and a final CGI rating of "much improved or "very much improved".
次要结局
- The onset of response to treatment, using the time to a sustained response as criterion
- Side effect profiles, Quality of life, Cognitive functioning