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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-17
SponsorUniversity of California, San Diego

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

No trial groups listed

Sponsors and collaborators

University of California, San Diego

Lead sponsor

Rady Children's Hospital, San Diego

Collaborator