Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol
Abstract Background Adolescent 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, a...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | BMC Psychiatry |
| Online Access: | https://doi.org/10.1186/s12888-023-05221-w |
| _version_ | 1797647227954397184 |
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| author | Yuqian He Xieyu Gan Xuemei Li Ting Wang Jie Li Tingting Lei Yajie Huang Ruibing Liu Fei Chen Teng Teng Yuxin Xie Xuan Ouyang Xinyu Zhou |
| author_facet | Yuqian He Xieyu Gan Xuemei Li Ting Wang Jie Li Tingting Lei Yajie Huang Ruibing Liu Fei Chen Teng Teng Yuxin Xie Xuan Ouyang Xinyu Zhou |
| author_sort | Yuqian He |
| collection | DOAJ |
| description | Abstract Background Adolescent 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. Methods We 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 registration This protocol was registered at ClinicalTrials.gov with Identifier: NCT05814640. |
| first_indexed | 2024-03-11T15:14:17Z |
| format | Article |
| id | doaj.art-e8989082bb1a4ce5b92ba103cd4fccf2 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-03-11T15:14:17Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-e8989082bb1a4ce5b92ba103cd4fccf22023-10-29T12:32:00ZengBMCBMC Psychiatry1471-244X2023-10-0123111110.1186/s12888-023-05221-wSequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocolYuqian He0Xieyu Gan1Xuemei Li2Ting Wang3Jie Li4Tingting Lei5Yajie Huang6Ruibing Liu7Fei Chen8Teng Teng9Yuxin Xie10Xuan Ouyang11Xinyu Zhou12Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Neurology, The Second Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychology, The Second Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityDepartment of Psychiatry, The Second Xiangya Hospital, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, Central South UniversityDepartment of Psychiatry, The Second Xiangya Hospital, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, Central South UniversityDepartment of Psychiatry, The First Affiliated Hospital of Chongqing Medical UniversityAbstract Background Adolescent 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. Methods We 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 registration This protocol was registered at ClinicalTrials.gov with Identifier: NCT05814640.https://doi.org/10.1186/s12888-023-05221-w |
| spellingShingle | Yuqian He Xieyu Gan Xuemei Li Ting Wang Jie Li Tingting Lei Yajie Huang Ruibing Liu Fei Chen Teng Teng Yuxin Xie Xuan Ouyang Xinyu Zhou Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol BMC Psychiatry |
| title | Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol |
| title_full | Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol |
| title_fullStr | Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol |
| title_full_unstemmed | Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol |
| title_short | Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol |
| title_sort | sequenced treatment alternatives to relieve adolescent depression star ad a multicentre open label randomized controlled trial protocol |
| url | https://doi.org/10.1186/s12888-023-05221-w |
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