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Recruiting Phase 1/2

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

NCT05814640 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2023-02-20
Last updated
2026-01-27

Condition(s) studied

DepressionSequestra

Investigational drug(s) / intervention(s)

Fluoxetine →Sertraline →Vortioxetine →Duloxetine →Aripiprazole →Lithium Carbonate →Olanzapine →GCBT

Fluoxetine: Commonly used oral antidepressant.

Sertraline: Commonly used oral antidepressant.

Vortioxetine: Commonly used oral antidepressant.

Duloxetine: Commonly used oral antidepressant.

Aripiprazole: Commonly used oral augmentation therapy for antidepressants

Lithium Carbonate: Commonly used oral augmentation therapy for antidepressants.

Olanzapine: Commonly used oral augmentation therapy for antidepressants.

GCBT: Commonly used intervention therapy of psychotherapy.

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
18 Years
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Change in CDRS-R (Children's Depression Rating Scale) scores from baseline — 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
    Clinical response (≥ 50% reduction in CDRS-R scores from baseline)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Chongqing Medical University Chongqing Province Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05814640 on ClinicalTrials.gov ↗ ← All trials in China