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

Depression Clinical Trial

Official title:
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05814640
Study type Interventional
Source First Affiliated Hospital of Chongqing Medical University
Contact Xinyu Zhou
Phone 15823996993
Email zhouxinyu@cqmu.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date February 20, 2023
Completion date July 1, 2027
View Details
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