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Recruiting Phase 1, Phase 2 NCT05814640

NCT05814640 Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

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Clinical Trial Summary
NCT ID NCT05814640
Status Recruiting
Phase Phase 1, Phase 2
Sponsor First Affiliated Hospital of Chongqing Medical University
Condition Depression
Study Type INTERVENTIONAL
Enrollment 520 participants
Start Date 2023-02-20
Primary Completion 2026-12-31

Trial Parameters

Condition Depression
Sponsor First Affiliated Hospital of Chongqing Medical University
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 520
Sex ALL
Min Age 13 Years
Max Age 18 Years
Start Date 2023-02-20
Completion 2026-12-31
Interventions
FluoxetineSertralineVortioxetine

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Brief 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 Criteria

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

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