Phase 3 Reboxetine Treatment in Depressed Children and Adolescents an 8-Week, Open Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The aim of the present study is to prospectively assess the anti-depressant effectiveness of reboxetine in children and adolescents, as compared with fluoxetine, in a randomized controlled open-label trial.
详细描述
Introduction: Depression is a prevalent disorder involving 3% of children and 8% of adolescents (Birmaher et al, 1996). Reboxetine, a highly selective norepinephrine reuptake inhibitor, is a representative of a fairly new class of antidepressant agents with specificity for the noradrenergic system (Kasper et al., 2000). Long-term clinical trials of reboxetine treatment have demonstrated that reboxetine is significantly more effective than placebo in the treatment of major depression in adult (Versiani et al., 1999) and elderly (> 65 years) (Rampello et al., 2005) patients. These long-term studies demonstrated that rebxetine was well tolerated. Its adverse events were mild in severity and did not require modification of the study medication (Rampello et al., 2005; Versiani et al., 1999). Few reports were published on the use of reboxetine in children and adolescents with attention deficit/hyperactivity disorder (ADHD) (e.g., Mozes et al., 2005). In our previous study (Ratner et al., 2005), we assessed the effectiveness of reboxetine in a 6-week, prospective, open-label study. Thirty-one children and adolescents with ADHD were treated with reboxetine (4 mg/day), with a significant decrease in ADHD symptoms on all scales measured. To the best of our knowledge, no studies were published on the use of reboxetine in the treatment of depressed children.
Fluoxetine is the drug of choice in the treatment of depression in children and adolescents. Fluoxetine was found to be effective and well tolerated in several studies, including double blind controlled ones (e.g., March et al., 2004).
The aim of the present study was to prospectively assess the anti-depressant effectiveness of reboxetine in children and adolescents, as compared with fluoxetine, in a randomized controlled open-label trial.
Methods:
- The study is a randomized controlled open-label one.
- Sixty children and adolescents 6-18 years old will participate.
- Inclusion criteria:
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of major depressive disorder or a dysthimic disorder according to DSM-IV-TR.
- •Drug naïve or without chronic medication for at least one month.
- •Only children who agree to participate and whose parents will sign and informed consent form will be included.
排除标准
- •A diagnosis of a psychotic disorder or bipolar disorder.
- •Mental retardation.
- •Alcohol or drug abuse
- •Chronic medical condition
- •Girls (> 12 years) will not be included in the study if a possibility of pregnancy during the study exists.