Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
研究概览
简要总结
This project aims to investigate the effectiveness of existing common antidepressants and to provide new evidence for depressed children and adolescents who are not responding to their first treatment.
详细描述
This is an open-label Sequential Multiple Assignment Randomized Trial (SMART) of 16 weeks duration with two levels, each stage 8 weeks. In phase 1, adolescents with MDD will be selected into fluoxetine or fluoxetine combination CBT therapy groups and the choice of treatment will be at the discretion of the patient. Subjects who fail to respond will enter phase 2 randomization， where patients will be randomly assigned to oral sertraline, votioxetine, duloxetine or adding one of aripiprazole, lithium carbonate, and olanzapine to fluoxetine. The primary outcome of the treatment phase is the treatment remission rate and response rate. Secondary outcomes included: symptom scale; Quality of life; Sleep therapy; Symptoms of anxiety; Rumination and safety assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Both the patient and the psychiatrist know which group they are allocated to, while the outcome assessor and data analyst are kept blind to the allocation. The clinicians providing the intervention do not perform the assessment and are unaware of the results.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 - 18
- •As assessed by K-SADS-PL, it meets the DSM-V criteria for MDD with non-psychotic symptoms
- •Score≥40 on the CDRS-R
- •Participants with suicidal ideation are eligible, as long as clinicians consider outpatient treatment to be safe
- •Sufficient audio-visual level to complete this study
- •Written informed consent was obtained from patients and at least one of their parents
排除标准
- •History of bipolar disorder, schizophrenia, autism, eating disorders, primary obsessive compulsive disorder, pervasive developmental disorder, or psychosis not otherwise specified
- •History of serious physical illnesses
- •Substance abuse or dependence
- •Current depressive episode with clear suicidal plans or suicidal behavior
- •Requires inpatient treatment for psychiatric disorders
- •Severe mental disorders requiring
- •2 or more failed trials of antidepressant drugs: each trial for at least 8 weeks, with the last 4 weeks at full dose (e.g. fluoxetine 40mg/d, citalopram 40mg/d, escitalopram 20mg/d, sertraline 150mg/d )
- •History of clear-cut intolerability of, or lack of effect with, an adequate trial of at least one protocol treatment option
- •Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment
- •Taking or administering antidepressants within 5 half-lives
- •Received modified electroconvulsive therapy within 12 months
- •If female, is pregnant
研究组 & 干预措施
Fluoxetine
Dosage form: po Dosage: 10-60mg Frequency: qn Course of treatment: 8 weeks. At week 8, patients will be evaluated as "in " or "not in remission." "Patients who are not in remission" will be randomized to phase II treatment based on the patient's wishes.
干预措施: Fluoxetine (Drug)
group cognitive behavioral therapy（GCBT）
GCBT was administered in addition to fluoxetine and consisted of 11 sessions for 8 weeks. It lasts 90 to 120 minutes, once or twice a week. At week 8, patients will be evaluated as "in remission" or "not in remission." "Patients who are not in remission" will be randomized to phase II treatment based on the patient's wishes.
干预措施: GCBT (Behavioral)
Sertraline
dosage form: po dosage:25-200mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given Sertraline as a switching treatment to fluoxetine.
干预措施: Sertraline (Drug)
Duloxetine
dosage form: po dosage: 60-120mg frequency: qn duration: At Week 8, patients assessed as 'non-remission' will be given duloxetine as an add-on treatment to fluoxetine.
干预措施: Duloxetine (Drug)
Aripiprazole
dosage form: po dosage: 2.5-15mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given aripiprazole as an add-on treatment to fluoxetine.
干预措施: Aripiprazole (Drug)
Lithium carbonate
dosage form: po dosage: 125-500mg frequency: qn duration: At Week 8, patients assessed as 'non-response' will be given lithium carbonate as an add-on treatment to fluoxetine.
干预措施: Lithium Carbonate (Drug)
Olanzapine
dosage form:po dosage: 1.25-10mg frequency:qn duration: At Week 8, patients assessed as 'non-rremission' will be given olanzapine as an add-on treatment to fluoxetine.
干预措施: Olanzapine (Drug)
Vortioxetine
dosage form: po dosage: 10-20mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given votioxetine as a switching treatment to fluoxetine.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
时间窗: Baseline of treatment period, 2 weeks, 1 month, 2 months, 3 months，4months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Clinical response (≥ 50% reduction in CDRS-R scores from baseline)
次要结局
- Change in BDI-II (Baker Depression Scale) scores from baseline(Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months)
- Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline(Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months)
- Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline(Baseline of treatment period, 1 month, 2 months, 3 months，4 months.)
- Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline(Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months)
- Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline(Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months)
- Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline(The treatment period was 1 month, 2 months, 3 months，4 months.)
- Change in HCL-32（Hypomania Symptom Checklist-32）(Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months)
- Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)(Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months)
- Change in RSS (Ruminative Responses Scale)(The treatment period was 1 month, 2 months.)
研究者
Xinyu Zhou
professor
First Affiliated Hospital of Chongqing Medical University