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.
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.
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)
Adolescents ages 13-17 with depression diagnosis
Cohort
Prospective
Not listed
Gut microbiome composition
Gut microbiome composition will be characterized by analysis of stool samples
Efficacy of fluoxetine to treat depression symptoms in adolescents
Fluoxetine success will be characterized by change, from baseline to week 6 follow-up, of Children's Depression Rating Scale, Revised (CDRS-R) scores.
Efficacy of fluoxetine to improve self-reported depression symptoms in adolescents
Fluoxetine success will be characterized by the change, from baseline to week 6 follow-up, of self-reported depression symptom severity indicated by Mood and Feelings Questionnaire (MFQ) scores.
Efficacy of fluoxetine to treat anxiety symptoms in adolescents
Fluoxetine success will be characterized by the change, from baseline to week 6 follow-up, of self-reported severity of recent anxiety symptoms indicated by the Screen for Child Anxiety Related Disorders (SCARED) scores.
Pharmacogenetic (PGx) metabolizer status
Patients are divided into metabolic phenotype groups denoted as poor, intermediate, and ultrarapid metabolizers based on their specific variant profile of pharmacokinetic genes.
Steady-state plasma concentrations of fluoxetine
Steady-state plasma sample concentrations of fluoxetine and (active metabolite norfluoxetine).
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University of California, San Diego
Lead sponsor
Rady Children's Hospital, San Diego
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
