Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-02 @ 4:45 AM
Study NCT ID:
NCT07011693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)
Sponsor:
Xinyu Zhou
Organization:
Study Overview
Official Title:
Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-I
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: