NCT05814640

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

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: First Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Fluoxetine	Commonly used oral antidepressant.
DRUG	Sertraline	Commonly used oral antidepressant.
DRUG	Vortioxetine	Commonly used oral antidepressant.
DRUG	Duloxetine	Commonly used oral antidepressant.
DRUG	Aripiprazole	Commonly used oral augmentation therapy for antidepressants
DRUG	Lithium Carbonate	Commonly used oral augmentation therapy for antidepressants.
DRUG	Olanzapine	Commonly used oral augmentation therapy for antidepressants.
BEHAVIORAL	GCBT	Commonly used intervention therapy of psychotherapy.

Timeline

• Start date: 2023-02-20
• Primary completion: 2026-12-31
• Completion: 2027-07-01
• First posted: 2023-04-18
• Last updated: 2026-01-27

Locations

1 site across 1 country: China