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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 17 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Study sites (1)

CA