A Randomized Controlled Trial of Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Y-BOCS score
研究概览
简要总结
To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole
详细描述
To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole, and to observe the indicators of improving patients' cognitive function and adverse drug reactions, so as to provide evidence-based evidence for supplementing the treatment guidelines for obsessive-compulsive disorder
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
- None
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V), as well as the definition of refractory OCD, are as follows: failure to respond to oral treatment with at least two effective doses of antidepressants, including: Fluoxetine (≥20mg/ d), fluvoxamine (≥200mg/d), sertraline (≥150mg/d), and paroxetine (≥ 40mg/d) were all treated for at least 12 weeks. The Yale-Brown compulsive scale (Y-BOCS) score decreased by < 35%.
- •The total score of Yale- Brown compulsion scale (Y-BOCS) ≥16 points. (3)age 12 ~ 45 years.
排除标准
- •Exclusion of severe organic brain disease;
- •Severe physical illness;
- •Other mental disorders such as tics, disruptive disorders, eating disorders and autism spectrum disorders;
- •Pediatric streptococcal infection causedby autoimmune neuropsychiatric disease (PANDAS);
- •Alcohol and drug dependence; Angle-closure glaucoma;
- •Suicidal tendencies;
- •Previous history of drug allergies related to research;
- •Pregnant and lactating women.
研究组 & 干预措施
sertraline combined with fluvoxamine
Sertraline combined with fluvoxamine treatment group: Gradually add the drug to the treatment dose, and monitor the symptom change, scale score, blood drug concentration and other indicators
干预措施: sertraline fluvoxamine (Drug)
sertraline combined with aripiprazole
sertraline combined with aripiprazole treatment group:Gradually add the drug to the treatment dose, and monitor the symptom change, scale score, blood drug concentration and other indicators
干预措施: sertraline (Drug)
结局指标
主要结局
Y-BOCS score
时间窗: 12 weeks
Treatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks). Treatment recovery: Y-BOCS score below 8 (12 weeks)
Ratio of Y-BOCS score reduction from baseline
时间窗: 12 weeks
Treatment effectiveness was defined as a reduction of ≥35% in Y-BOCS score compared to baseline(12 weeks).
次要结局
未报告次要终点