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NOT YET RECRUITING
NCT06633497

Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn about the role of the human gut microbiome in antidepressant treatment response in adolescents with Major Depressive Disorder (MDD). Specifically, the study aims to collect microbiota samples of adolescents treated with fluoxetine, over the span of 8-weeks, to: * determine the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression. * test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine * investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine. Depression symptom severity will be evaluated upon enrollment and 6-weeks into antidepressant treatment.

Key Details

Gender

All

Age Range

13 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-11

Completion Date

2026-10

Last Updated

2024-11-04

Healthy Volunteers

Yes

Locations (1)

Rady Children's Hospital San Diego

San Diego, California, United States