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

NCT06633497 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-11-04

No results posted yet for this study

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.

Conditions

  • Depression in Adolescence

Sponsors & Collaborators

Principal Investigators

  • Rob Knight, PhD · University of California, San Diego

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633497 on ClinicalTrials.gov