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NCT Number: NCT06633497

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-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.

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Key information

Conditions

Depression in Adolescence

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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.

    Gut microbiome composition will be characterized by analysis of stool samples

  2. Efficacy of fluoxetine to treat depression symptoms in adolescents

    Time frame: 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.

Secondary outcomes

  1. Efficacy of fluoxetine to improve self-reported depression symptoms in adolescents

    Time frame: The MFQ will be administered at baseline and week 6.

    Fluoxetine success will be characterized by the change, from baseline to week 6 follow-up, of self-reported depression symptom severity indicated by Mood and Feelings Questionnaire (MFQ) scores.

  2. Efficacy of fluoxetine to treat anxiety symptoms in adolescents

    Time frame: The SCARED will be administered at baseline and week 6.

    Fluoxetine success will be characterized by the change, from baseline to week 6 follow-up, of self-reported severity of recent anxiety symptoms indicated by the Screen for Child Anxiety Related Disorders (SCARED) scores.

  3. Pharmacogenetic (PGx) metabolizer status

    Time frame: A saliva sample is collected for pharmacogenetic analysis at baseline

    Patients are divided into metabolic phenotype groups denoted as poor, intermediate, and ultrarapid metabolizers based on their specific variant profile of pharmacokinetic genes.

  4. Steady-state plasma concentrations of fluoxetine

    Time frame: Sample collected at week 6

    Steady-state plasma sample concentrations of fluoxetine and (active metabolite norfluoxetine).

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Besterman, MD

CONTACT

[email protected]

8589668145

Abbey Albertazzi, MA

CONTACT

[email protected]

8589661700 ext. 221939

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Rady Children's Hospital, San Diego

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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