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NCT06633497 · ClinicalTrials.gov registry record
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
A clinical trial, sponsored by University of California, San Diego.
- Not yet
- Registry status
- 100
- Enrollment target
NCT06633497: Clinical Trial study, sponsored by University of California, San Diego.
NCT06633497 is a clinical trial that has not yet begun recruiting, run by University of California, San Diego. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06633497 has not yet begun recruiting, sponsored by University of California, San Diego.
- NOT YET RECRUITING
- Registry status
- 100 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Gut microbiome composition will be characterized by analysis of stool samples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-11 |
| Est. Completion | 2026-10 |
What is known before NCT06633497 opens enrollment
NCT06633497 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06633497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06633497 about?
NCT06633497 is a clinical study titled "Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.". 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-...
What is the current status of trial NCT06633497?
This trial is currently not yet recruiting. The enrollment target is 100 participants. The study started on 2024-11. Estimated completion is 2026-10.
Who is sponsoring clinical trial NCT06633497?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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