DepressionPhase 1/2STAR-ADNCT05814640
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
A Phase 1/2 study testing Fluoxetine, Sertraline and Vortioxetine in people with Depression and Sequestra, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression, Sequestra
- What is being tested?
- Fluoxetine, Sertraline and Vortioxetine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 1 Jul 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Province, 400000
Zhou Xinyu, Doctor of Philosophy, 15823996993, zhouxinyu@cqmu.edu.cn
About this study
Official title: Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Depression, Sequestra
- Being tested
- Fluoxetine, Sertraline, Vortioxetine, Duloxetine, Aripiprazole
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Commonly used oral antidepressant.
SertralineDrug
Commonly used oral antidepressant.
VortioxetineDrug
Commonly used oral antidepressant.
DuloxetineDrug
Commonly used oral antidepressant.
AripiprazoleDrug
Commonly used oral augmentation therapy for antidepressants
Lithium CarbonateDrug
Commonly used oral augmentation therapy for antidepressants.
OlanzapineDrug
Commonly used oral augmentation therapy for antidepressants.
GCBTBehavioural
Commonly used intervention therapy of psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | 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. Receives: Drug: Fluoxetine |
| group cognitive behavioral therapy（GCBT） | Experimental | 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. Receives: Behavioral: GCBT |
| Sertraline | Experimental | 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. Receives: Drug: Sertraline |
| Vortioxetine | Experimental | 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. Receives: Drug: Vortioxetine |
| Duloxetine | Experimental | 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. Receives: Drug: Duloxetine |
| Aripiprazole | Experimental | 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. Receives: Drug: Aripiprazole |
| Lithium carbonate | Experimental | 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. Receives: Drug: Lithium Carbonate |
| Olanzapine | Experimental | 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. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Clinical response (≥ 50% reduction in CDRS-R scores from baseline)
Measured: 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
Secondary outcomes (9)
Change in BDI-II (Baker Depression Scale) scores from baseline
Change in BDI-II (Baker Depression Scale) scores from baseline
Measured: 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
Improvement in anxiety (SCARED minus the scores）
Measured: 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)
The severity of the suicide risk
Measured: 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 PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Improvement in sleep status (PSQI minus the scores）
Measured: 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
Improvement of children's quality of life（PedsQL4.0 minus the scores)
Measured: 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-S (Clinical Global Impressions-Severity Scales) scores from baseline
Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged）
Measured: Baseline of treatment period, 1 month, 2 months, 3 months，4 months.
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration）
Measured: The treatment period was 1 month, 2 months, 3 months，4 months.
Change in RSS (Ruminative Responses Scale)
The level of improvement in negative thinking（he higher the total score, the more reflective thinking The more severe it is）
Measured: The treatment period was 1 month, 2 months.
Change in HCL-32（Hypomania Symptom Checklist-32）
Assess the patient's hypomanic state
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- After receiving fluoxetine and fluoxetine combined with cognitive-behavioral therapy, the next stage of treatment is determined by the patient's response (remission and non-remission) and is scheduled according to the patient's wishes and random assignment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Second Xiangya Hospital of Central South University, Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814640
- Sponsor's protocol ID
- 1stChongqingMU--ZXY
- Acronym
- STAR-AD
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gunlicks-Stoessel M, Mufson L, Bernstein G, Westervelt A, Reigstad K, Klimes-Dougan B, Cullen K, Murray A, Vock D. Critical Decision Points for Augmenting Interpersonal Psychotherapy for Depressed Adolescents: A Pilot Sequential Multiple Assignment Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):80-91. doi: 10.1016/j.jaac.2018.06.032. Epub 2018 Oct 27.
PubMed 30577943Hawton K, van Heeringen K. Suicide. Lancet. 2009 Apr 18;373(9672):1372-81. doi: 10.1016/S0140-6736(09)60372-X.
PubMed 19376453van Ettekoven KM, Rasing SPA, Vermulst AA, Engels RCME, Kindt KCM, Creemers DHM. Cross-Lagged Associations between Depressive Symptoms and Response Style in Adolescents. Int J Environ Res Public Health. 2020 Feb 21;17(4):1380. doi: 10.3390/ijerph17041380.
PubMed 32098035Twenge JM, Cooper AB, Joiner TE, Duffy ME, Binau SG. Age, period, and cohort trends in mood disorder indicators and suicide-related outcomes in a nationally representative dataset, 2005-2017. J Abnorm Psychol. 2019 Apr;128(3):185-199. doi: 10.1037/abn0000410. Epub 2019 Mar 14.
PubMed 30869927McCarty CA, Weisz JR. Effects of psychotherapy for depression in children and adolescents: what we can (and can't) learn from meta-analysis and component profiling. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):879-86. doi: 10.1097/chi.0b013e31805467b3.
PubMed 17581452Birmaher B, Brent D; AACAP Work Group on Quality Issues; Bernet W, Bukstein O, Walter H, Benson RS, Chrisman A, Farchione T, Greenhill L, Hamilton J, Keable H, Kinlan J, Schoettle U, Stock S, Ptakowski KK, Medicus J. Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 2007 Nov;46(11):1503-26. doi: 10.1097/chi.0b013e318145ae1c.
PubMed 18049300Luxton R, Kyriakopoulos M. Depression in children and young people: identification and management NICE guidelines. Arch Dis Child Educ Pract Ed. 2022 Feb;107(1):36-38. doi: 10.1136/archdischild-2020-320020. Epub 2021 May 10. No abstract available.
PubMed 33972346MacQueen GM, Frey BN, Ismail Z, Jaworska N, Steiner M, Lieshout RJ, Kennedy SH, Lam RW, Milev RV, Parikh SV, Ravindran AV; CANMAT Depression Work Group. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 6. Special Populations: Youth, Women, and the Elderly. Can J Psychiatry. 2016 Sep;61(9):588-603. doi: 10.1177/0706743716659276. Epub 2016 Aug 2.
PubMed 27486149Cheung AH, Zuckerbrot RA, Jensen PS, Laraque D, Stein REK; GLAD-PC STEERING GROUP. Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part II. Treatment and Ongoing Management. Pediatrics. 2018 Mar;141(3):e20174082. doi: 10.1542/peds.2017-4082.
PubMed 29483201Feng Y, Xiao L, Wang WW, Ungvari GS, Ng CH, Wang G, Xiang YT. Guidelines for the diagnosis and treatment of depressive disorders in China: The second edition. J Affect Disord. 2019 Jun 15;253:352-356. doi: 10.1016/j.jad.2019.04.104. Epub 2019 May 1.
PubMed 31078835March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
PubMed 15315995Mufson L, Dorta KP, Wickramaratne P, Nomura Y, Olfson M, Weissman MM. A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. Arch Gen Psychiatry. 2004 Jun;61(6):577-84. doi: 10.1001/archpsyc.61.6.577.
PubMed 15184237Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
PubMed 18314433Emslie GJ, Mayes T, Porta G, Vitiello B, Clarke G, Wagner KD, Asarnow JR, Spirito A, Birmaher B, Ryan N, Kennard B, DeBar L, McCracken J, Strober M, Onorato M, Zelazny J, Keller M, Iyengar S, Brent D. Treatment of Resistant Depression in Adolescents (TORDIA): week 24 outcomes. Am J Psychiatry. 2010 Jul;167(7):782-91. doi: 10.1176/appi.ajp.2010.09040552. Epub 2010 May 17.
PubMed 20478877El-Hage W. [Roadmap for therapeutic strategies of treatment resistant depression]. Presse Med. 2016 Mar;45(3):320-2. doi: 10.1016/j.lpm.2016.02.001. Epub 2016 Mar 9. No abstract available. French.
PubMed 26970939