Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 6
研究概览
简要总结
The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
详细描述
The TORDIA study aims to develop useful clinical guidelines for the care and management of adolescent depression. Adolescents ages 12 to 18, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a 12-week randomized treatment study that includes one of four conditions: (1) switching to an alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a different non-SSRI antidepressant and receiving CBT. This is a double-blind study, which means that neither the participant nor the clinical staff will know which of the three possible medications has been assigned. Participants who respond to the assigned treatment will receive 12 additional weeks of the same treatment. Those who do not appear to be getting better will be offered 12 weeks of an alternative, individualized treatment plan based on each participant's particular needs. All participants will receive follow-up psychiatric evaluations for 12 months after the 12-week continuation phase of the study, regardless of treatment adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.
干预措施: Fluoxetine (Drug)
1
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.
干预措施: Citalopram (Drug)
2
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant.
干预措施: Venlafaxine (Drug)
3
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
干预措施: Fluoxetine (Drug)
3
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
3
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
干预措施: Citalopram (Drug)
4
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
干预措施: Venlafaxine (Drug)
4
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
