Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
NCT ID: NCT05814640
Last Updated: 2026-01-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
520 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-02-20
Study Completion Date
2027-07-01
Brief Summary
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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.
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Detailed Description
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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
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Depression
Sequestra
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Fluoxetine
Intervention Type
DRUG
Commonly used oral antidepressant.
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.
Group Type
EXPERIMENTAL
GCBT
Intervention Type
BEHAVIORAL
Commonly used intervention therapy of psychotherapy.
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.
Group Type
EXPERIMENTAL
Sertraline
Intervention Type
DRUG
Commonly used oral antidepressant.
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.
Group Type
EXPERIMENTAL
Vortioxetine
Intervention Type
DRUG
Commonly used oral antidepressant.
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.
Group Type
EXPERIMENTAL
Duloxetine
Intervention Type
DRUG
Commonly used oral antidepressant.
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.
Group Type
EXPERIMENTAL
Aripiprazole
Intervention Type
DRUG
Commonly used oral augmentation therapy for antidepressants
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.
Group Type
EXPERIMENTAL
Lithium Carbonate
Intervention Type
DRUG
Commonly used oral augmentation therapy for antidepressants.
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.
Group Type
EXPERIMENTAL
Olanzapine
Intervention Type
DRUG
Commonly used oral augmentation therapy for antidepressants.
Interventions
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Fluoxetine
Commonly used oral antidepressant.
Intervention Type
DRUG
Sertraline
Commonly used oral antidepressant.
Intervention Type
DRUG
Vortioxetine
Commonly used oral antidepressant.
Intervention Type
DRUG
Duloxetine
Commonly used oral antidepressant.
Intervention Type
DRUG
Aripiprazole
Commonly used oral augmentation therapy for antidepressants
Intervention Type
DRUG
Lithium Carbonate
Commonly used oral augmentation therapy for antidepressants.
Intervention Type
DRUG
Olanzapine
Commonly used oral augmentation therapy for antidepressants.
Intervention Type
DRUG
GCBT
Commonly used intervention therapy of psychotherapy.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Age 13 - 18
2. As assessed by K-SADS-PL, it meets the DSM-V criteria for MDD with non-psychotic symptoms
3. Score≥40 on the CDRS-R
4. Participants with suicidal ideation are eligible, as long as clinicians consider outpatient treatment to be safe
5. Sufficient audio-visual level to complete this study
6. Written informed consent was obtained from patients and at least one of their parents
2. As assessed by K-SADS-PL, it meets the DSM-V criteria for MDD with non-psychotic symptoms
3. Score≥40 on the CDRS-R
4. Participants with suicidal ideation are eligible, as long as clinicians consider outpatient treatment to be safe
5. Sufficient audio-visual level to complete this study
6. Written informed consent was obtained from patients and at least one of their parents
Exclusion Criteria
1. History of bipolar disorder, schizophrenia, autism, eating disorders, primary obsessive compulsive disorder, pervasive developmental disorder, or psychosis not otherwise specified
2. History of serious physical illnesses
3. Substance abuse or dependence
4. Current depressive episode with clear suicidal plans or suicidal behavior
5. Requires inpatient treatment for psychiatric disorders
6. Severe mental disorders requiring
7. 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 )
8. History of clear-cut intolerability of, or lack of effect with, an adequate trial of at least one protocol treatment option
9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment
10. Taking or administering antidepressants within 5 half-lives
11. Received modified electroconvulsive therapy within 12 months
12. If female, is pregnant
2. History of serious physical illnesses
3. Substance abuse or dependence
4. Current depressive episode with clear suicidal plans or suicidal behavior
5. Requires inpatient treatment for psychiatric disorders
6. Severe mental disorders requiring
7. 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 )
8. History of clear-cut intolerability of, or lack of effect with, an adequate trial of at least one protocol treatment option
9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment
10. Taking or administering antidepressants within 5 half-lives
11. Received modified electroconvulsive therapy within 12 months
12. If female, is pregnant
Minimum Eligible Age
13 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Second Affiliated Hospital of Chongqing Medical University
OTHER
Sponsor Role
collaborator
Second Xiangya Hospital of Central South University
OTHER
Sponsor Role
collaborator
Children's Hospital of Chongqing Medical University
OTHER
Sponsor Role
collaborator
First Affiliated Hospital of Chongqing Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Xinyu Zhou
professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Province, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://apps.who.int/iris/handle/10665/254610
Depression and Other Common Mental Disorders Global Health Estimates
https://www.nice.org.uk/guidance/ng222
Depression in adults: recognition and management
https://www.menet.com.cn/
Review and opportunity analysis of antidepressant drug market in China
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1stChongqingMU--ZXY
Identifier Type: -
Identifier Source: org_study_id
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