NCT07011693

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Xinyu Zhou · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.

Detailed description

This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment. Adolescents ages 12 to 17, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) at least 8 weeks and still experiencing depression, participate in a 8-week randomized treatment study that includes one of three conditions: (1) switching to sertraline , (2) switching to duloxetine , (3) augmentation of their original SSRI with aripiprazole.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Sertraline	Commonly used oral antipsychotics intervention therapy.
DRUG	Agomelatine	Commonly used oral antipsychotics intervention therapy.
DRUG	Aripiprazole	Commonly used oral antipsychotics intervention therapy.

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China