Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633497
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
For this project the investigators are interested in changes in the gut microbiome associated with adolescent depression and the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression It is hypothesized that the composition of the human gut microbiome alters the response to fluoxetine of adolescents with depression This study aims to collect gut microbiota of adolescents being treated with antidepressants at several timepoints to 1 determine the efficacy of fluoxetine to treat depression 2 test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine and 3 investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine Adolescent patients with clinically significant depressive symptoms who are prescribed fluoxetine from Rady Childrens Hospital San Diego RCHSD Inpatient Child and Adolescent Psychiatry Services CAPS will be recruited for this study Up to twelve stool samples are planned to be collected including prior to start of antidepressant treatment for a baseline measure of gut microbiome composition daily samples over during the first week of fluoxetine treatment and then biweekly collections until the end of the 8-week study duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None