Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents. (NCT06633497)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Rady Children's Hospital San Diego — San Diego, California
Age range: 13 Years to 17 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Rady Children's Hospital San Diego — San Diego, California
📞 Contact the Study Coordinator
Phone: (858) 966-8145
Email: abesterman@rchsd.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.