Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gut microbiome composition
研究概览
简要总结
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.
详细描述
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 Children's 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Gut microbiome composition
时间窗: 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.
Gut microbiome composition will be characterized by analysis of stool samples
Efficacy of fluoxetine to treat depression symptoms in adolescents
时间窗: The CDRS-R will be administered at baseline and week 6.
Fluoxetine success will be characterized by change, from baseline to week 6 follow-up, of Children's Depression Rating Scale, Revised (CDRS-R) scores.
次要结局
- Efficacy of fluoxetine to improve self-reported depression symptoms in adolescents(The MFQ will be administered at baseline and week 6.)
- Steady-state plasma concentrations of fluoxetine(Sample collected at week 6)
- Efficacy of fluoxetine to treat anxiety symptoms in adolescents(The SCARED will be administered at baseline and week 6.)
- Pharmacogenetic (PGx) metabolizer status(A saliva sample is collected for pharmacogenetic analysis at baseline)
研究者
Rob Knight
Professor
University of California, San Diego