Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- response rate of Children's Depression Rating Scale (CDRS-R) scores
研究概览
简要总结
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.
详细描述
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment. Adolescents ages 12 to 17, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) at least 8 weeks and still experiencing depression, participate in a 8-week randomized treatment study that includes one of three conditions: (1) switching to sertraline , (2) switching to duloxetine , (3) augmentation of their original SSRI with aripiprazole.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12-17;
- •As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;
- •Failed to respond to an initial SSRI trial: the trial at least 8 weeks, with the last of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent.
排除标准
- •Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;
- •MDD with psychotic symptoms;
- •Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;
- •Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (at least 8 weeks, with the last 4 of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent);
- •History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;
- •Current depressive episode with clear suicidal plans or behaviors;
- •Received modified electroconvulsive therapy within 3 months;
- •Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;
- •Substance abuse or dependence;
- •Female patients with pregnancy.
研究组 & 干预措施
Group1-sertraline
dosage form: po dosage:25-200mg frequency:qd duration: patients will be given sertraline as a switching treatment to SSRI.
干预措施: Sertraline (Drug)
Group 2-agomelatine
dosage form: po dosage:25-50mg frequency:qd duration: patients will be given agomelatine as a switching treatment to SSRI.
干预措施: Agomelatine (Drug)
Group 3-aripiprazole with original SSRI
dosage form: po dosage: 1.25-15mg frequency:qn duration: patientswill be given aripiprazole as an add-on treatment to original SSRI.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
response rate of Children's Depression Rating Scale (CDRS-R) scores
时间窗: Baseline of treatment period, 4 weeks, 8 weeks
The primary outcomes are the treatment response rate (reduction rate of CDRS-R≥50%). The CDRS-R is a scale consisting of 17 items that are evaluated by clinicians to assess the intensity of depressive symptoms in adolescents, with items scored on scales of 1 to 5 or 1 to 7, resulting in a possible total score range of 17 to 113，higher scores mean a worse outcome.
次要结局
- Change in Baker Depression Scale（BDI-II) scores from baseline(Baseline of treatment period, 4 weeks, 8 weeks)
- Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline(Baseline of treatment period, 4 weeks，8 weeks)
- Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline(Baseline of treatment period, 4 weeks, 8 weeks,)
- Adverse Event (AE) or Serious Adverse Event (SAE)(Baseline of treatment period, 1 month, 2 months,)
研究者
Xinyu Zhou
Professer
First Affiliated Hospital of Chongqing Medical University