Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
Part of paid clinical trials in San Diego, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT06633497
- Status
- Not Yet Recruiting
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Conditions
- Depression in Adolescence
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 17 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Nov 30, 2024
- Status verified
- Oct 2024
- Primary completion
- Sep 30, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
Primary Outcome Measure
Gut microbiome composition [ Time Frame: Stool samples will be collected at enrollment (baseline), then following enrollment: daily for the first 7 days and biweekly at weeks 2, 4, 6, and 8. ]
Central Contacts
- Aaron Besterman, MD8589668145
- Abbey Albertazzi, MA8589661700
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rady Children's Hospital San Diego | San Diego | California | 92123 | - |
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