NCT06633497

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

For this project the investigators are interested in changes in the gut microbiome associated with adolescent depression and the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression. It is hypothesized that the composition of the human gut microbiome alters the response to fluoxetine of adolescents with depression. This study aims to collect gut microbiota of adolescents being treated with antidepressants at several timepoints to (1) determine the efficacy of fluoxetine to treat depression, (2) test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine, and (3) investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine. Adolescent patients with clinically significant depressive symptoms who are prescribed fluoxetine, from Rady Children's Hospital San Diego (RCHSD) Inpatient Child and Adolescent Psychiatry Services (CAPS), will be recruited for this study. Up to twelve stool samples are planned to be collected, including prior to start of antidepressant treatment for a baseline measure of gut microbiome composition, daily samples over during the first week of fluoxetine treatment, and then biweekly collections until the end of the 8-week study duration.

Conditions

• Depression in Adolescence

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2024-10-09
• Last updated: 2024-11-04

Locations

1 site across 1 country: United States