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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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
Show all 12Show fewer
  • 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.

Xinyu Zhou contact

15823996993

zhouxinyu@cqmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Province, 400000

    Zhou Xinyu, Doctor of Philosophy, 15823996993, zhouxinyu@cqmu.edu.cn

    Recruiting

Other trials in China

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.

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 groups in NCT05814640
Study groupRoleWhat they receive
FluoxetineExperimentalDosage 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）ExperimentalGCBT 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
SertralineExperimentaldosage 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
VortioxetineExperimentaldosage 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
DuloxetineExperimentaldosage 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
AripiprazoleExperimentaldosage 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 carbonateExperimentaldosage 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
OlanzapineExperimentaldosage 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  1. First posted18 Apr 2023
  2. Study start20 Feb 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

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)
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 30577943

  • Hawton K, van Heeringen K. Suicide. Lancet. 2009 Apr 18;373(9672):1372-81. doi: 10.1016/S0140-6736(09)60372-X.

    PubMed 19376453

  • van 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 32098035

  • Twenge 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 30869927

  • McCarty 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 17581452

  • Birmaher 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 18049300

  • Luxton 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 33972346

  • MacQueen 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 27486149

  • Cheung 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 29483201

  • Feng 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 31078835

  • March 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 15315995

  • Mufson 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 15184237

  • Brent 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 18314433

  • Emslie 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 20478877

  • El-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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinyu Zhou (15823996993, zhouxinyu@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05814640, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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