Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814640
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-04-04
Brief Title:
Sequenced Treatment Alternatives to Relieve Adolescent Depression STAR-AD
Sponsor:
First Affiliated Hospital of Chongqing Medical University
Organization:
First Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
Sequenced Treatment Alternatives to Relieve Adolescent Depression STAR-AD a Multicentre Open-label Randomized Controlled Trial Protocol
Status:
RECRUITING
Status Verified Date:
2023-08
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:
STAR-AD
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
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
Study Oversight
Has Oversight DMC:
None
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?:
None