Substance Dependent Teens - Impact of Treating Depression Study 1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.
研究概览
简要总结
The purpose of this study is to evaluate the impact of treating depression on substance dependent teens.
详细描述
The primary study aim is to determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. The current community standard of care often withholds pharmacotherapy for depression in substance abusing adolescents, since it is often assumed that their depressions may remit with SUD treatment alone. However, this is an untested hypothesis in adolescents and one that we propose to test in the current study.
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
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder.
排除标准
- •History of or current psychosis, history of psychotic depression, bipolar disorder I or II, family history of first degree relative with bipolar I, lifetime history of non-substance induced Mania/Hypomania
- •Unstable chronic or serious medical illness
- •Currently pregnant
- •Take psychotrophic medication, past 2 months: medication or treatment for depression, clinically significant laboratory abnormality
研究组 & 干预措施
1
fluoxetine + CBT
干预措施: Fluoxetine + outpatient cognitive behavioral therapy (Drug)
1
fluoxetine + CBT
干预措施: fluoxetine (Drug)
2
placebo + CBT
干预措施: placebo + CBT (Drug)
结局指标
主要结局
To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.
时间窗: 16 weeks
次要结局
- To determine if the treatment of depression with fluoxetine + CBT, in depressed adolescents with SUD and CD will be more effective than placebo + CBT in reducing substance use and improving conduct symptoms.(16 weeks)