Evidence map›Paper›PMID 37891522›Full record

ArticleBMC psychiatry2023

Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol.

Yuqian He, Xieyu Gan, Xuemei Li, Ting Wang, Jie Li, Tingting Lei, Yajie Huang, Ruibing Liu, Fei Chen, Teng Teng and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05814640 (Sequenced Treatment Alternatives to Relieve Adolescent Depression), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05814640 phase1 / phase2recruitingnot on this map

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial

TypeinterventionalSponsorFirst Affiliated Hospital of Chongqing Medical UniversityRan2023 to 2027Enrolled520ConditionsDepression, SequestraArmsFluoxetine, Sertraline, Vortioxetine, Duloxetine, Aripiprazole
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Yuqian He *Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Xieyu Gan *Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Xuemei LiDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Ting WangDepartment of Psychology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Jie LiDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Tingting LeiDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Yajie HuangDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Ruibing LiuDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Fei ChenDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Teng TengDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China.
Yuxin XieDepartment of Psychiatry, The Second Xiangya Hospital, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, Central South University, Changsha, China.
Xuan OuyangDepartment of Psychiatry, The Second Xiangya Hospital, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, Central South University, Changsha, China. ouyangxuan@csu.edu.cn.
Xinyu ZhouDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, China. zhouxinyu@cqmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdolescent major depressive disorder (MDD) is a prevalent mental health problem with low treatment success rates. Whether fluoxetine or fluoxetine combined with cognitive-behavioural therapy (CBT) is the more effective initial treatment for adolescent MDD remains controversial, and few studies have investigated whether treatment switching or augmentation is preferred when the initial treatment is not working well.

methodsWe developed a multicentre open-label Sequential Multiple Assignment Randomized Trial (SMART) design, consisting of two phases lasting 8 weeks each. In phase 1 (at baseline), patients will be recruited and grouped in fluoxetine group or fluoxetine combined with CBT group by patient self-selection. In phase 2 (after 8 weeks of treatment), the nonresponders will be randomly assigned to six groups, in which participants will switch to sertraline, vortioxetine, or duloxetine or added aripiprazole, olanzapine, or lithium carbonate to fluoxetine. After the full 16 weeks of treatment, we will assess the long-term sustainability of the treatment effects by evaluating participants during their subsequent naturalistic treatment. The primary outcome will be the response rate, determined by the Children's Depression Rating Scale-Revised (CDRS-R). Secondary outcomes include the change in scores on the Beck Depression Inventory (BDI), the Screen for Child Anxiety-Related Emotional Disorders (SCARED) and the Safe Assessment. DISCUSSION: The results from this study will aid clinicians in making informed treatment selection decisions for adolescents with MDD.

trial registrationThis protocol was registered at ClinicalTrials.gov with Identifier: NCT05814640.

Indexed as

Cognitive Behavioral TherapyMajor Depressive DisorderAdolescentChildCombined Modality TherapyDepressionFluoxetineHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeFluoxetine

Identifiers

PMID37891522
PMCPMC10612344

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.