Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.

NCT06633497 | Not Yet Recruiting

• 1 other identifier: 807323
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Adolescence

Outcome Measures

Primary Outcomes (2)

• Gut microbiome composition

  Gut microbiome composition will be characterized by analysis of stool samples

  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.

• Efficacy of fluoxetine to treat depression symptoms in adolescents

  Fluoxetine success will be characterized by change, from baseline to week 6 follow-up, of Children's Depression Rating Scale, Revised (CDRS-R) scores.

  The CDRS-R will be administered at baseline and week 6.

Secondary Outcomes (4)

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

  The MFQ will be administered at baseline and 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

• Steady-state plasma concentrations of fluoxetine

  Sample collected at week 6

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents ages 13-17 with depression diagnosis

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

Study Officials

• Rob Knight, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Besterman, MD

CONTACT

8589668145; abesterman@rchsd.org

Abbey Albertazzi, MA

CONTACT

8589661700; aalbertazzi@rchsd.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 9, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)