Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- YBOCS
研究概览
简要总结
The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.
详细描述
The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary OCD diagnosis according to DSM IV criteria
- •current symptoms were responsible for significant distress
- •previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms
排除标准
- •presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol
- •current substance dependence or abuse,
- •current psychotic symptoms
- •current suicide risk
- •and current pregnancy or intention to get pregnant before the end of the treatment protocol
研究组 & 干预措施
Quetiapine augmentation
Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage
干预措施: Quetiapine (Drug)
Clomipramine augmentation
Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage
干预措施: Clomipramine (Drug)
结局指标
主要结局
YBOCS
时间窗: 12 weeks
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
次要结局
- CGI(12 weeks)
- Tolerability(weeks 0,2,4,8 and 12)
- Cardiotoxicity(week 0 and 2)
研究者
Juliana Belo Diniz
MD, PhD
University of Sao Paulo