About this trial
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.
Eligibility criteria
Qualifiers
Subjects from all ethnic backgrounds will be eligible to participate.
Having clinically significant depressive symptoms based on a score >40 on the Children's Depression Rating Scale-Revised
Prescribed more than 5mg of Fluoxetine (Prozac)
Has an identifiable legal guardian.
Disqualifiers
Has been taking a standing psychotropic medication in the past 6 months
Has been taking antibiotics or metformin during the past 6 months (known strong effects on gut microbiome)
Admitted to RCHSD CAPS post-overdose (potential strong effects on gut microbiome)
Currently using nicotine-containing substances (known strong effects on gut microbiome)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
University of California, San Diego
Lead sponsor
Rady Children's Hospital, San Diego
Collaborator