Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- YBOCS
研究概览
简要总结
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.
详细描述
Arm 1: SSRI (Fluoxetine 40mg* once a day) + Clomipramine 75mg* once a day.
Arm 2: SSRI (Fluoxetine 40mg* once a day) + Quetiapine 200mg* once a day.
Arm 3: SSRI (Fluoxetine 80mg* once a day) + Placebo once a day.
*or maximum tolerated dose
We hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant OCD patients in comparison to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •OCD diagnosis
- •YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
- •Previously signed informed consent to participate in this clinical trial
排除标准
- •Patients with 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
- •Current pregnancy or intention to get pregnant before the end of the treatment protocol
研究组 & 干预措施
Quetiapine (fluoxetine plus quetiapine)
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
干预措施: Quetiapine (fluoxetine plus quetiapine) (Drug)
Clomipramine (fluoxetine plus clomipramine)
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
干预措施: Clomipramine (fluoxetine plus clomipramine) (Drug)
Placebo (fluoxetine plus placebo)
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
干预措施: Placebo (fluoxetine plus placebo) (Drug)
结局指标
主要结局
YBOCS
时间窗: 12 weeks
Rates of improvement after 12 weeks of treatment based on the difference of initial and final Yale Brown Obsessive Compulsive Scale (YBOCS) scores for obsessions and compulsions
次要结局
- CGI(12 weeks)
- Cardiotoxicity(2 weeks)
- Plasma levels(weeks 2 and 12)
- Social Adaptation(12 weeks)
- BDI(12 weeks)
- QoL(12 weeks)
- Tolerability(weeks 0,1,2,3,4,8,12)
- BAI(12 weeks)
研究者
Juliana Belo Diniz
MD, PhD
University of Sao Paulo