Depression in AdolescenceNCT06633497
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
An observational study of Depression in Adolescence, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression in Adolescence
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents ages 13-17 with depression diagnosis
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
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.
Read the 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 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.
- Conditions
- Depression in Adolescence
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome composition
Gut microbiome composition will be characterized by analysis of stool samples
Measured: 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.
Measured: 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
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.
Measured: The MFQ will be administered at baseline and week 6.
Efficacy of fluoxetine to treat anxiety symptoms in adolescents
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.
Measured: The SCARED will be administered at baseline and week 6.
Pharmacogenetic (PGx) metabolizer status
Patients are divided into metabolic phenotype groups denoted as poor, intermediate, and ultrarapid metabolizers based on their specific variant profile of pharmacokinetic genes.
Measured: A saliva sample is collected for pharmacogenetic analysis at baseline
Steady-state plasma concentrations of fluoxetine
Steady-state plasma sample concentrations of fluoxetine and (active metabolite norfluoxetine).
Measured: Sample collected at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, Rob Knight, University of California, San Diego
- Investigators
- Rob Knight, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633497
- Sponsor's protocol ID
- 807323
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
- ClinicalTrials.gov ID
- NCT06633497
- Acronym / sponsor ID
- 807323
- Conditions
- Depression in Adolescence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Study start
- Nov 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents ages 13-17 with depression diagnosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
4 secondary outcomes
Efficacy of fluoxetine to improve self-reported depression symptoms in adolescents
Time frame: The MFQ will be administered at baseline and week 6.
Efficacy of fluoxetine to treat anxiety symptoms in adolescents
Time frame: The SCARED will be administered at baseline and week 6.
Pharmacogenetic (PGx) metabolizer status
Time frame: A saliva sample is collected for pharmacogenetic analysis at baseline
Steady-state plasma concentrations of fluoxetine
Time frame: Sample collected at week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Depression in Adolescence
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
Active, not recruiting
Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
Depressive Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Knight, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression in Adolescence, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aaron Besterman, MD (8589668145, abesterman@rchsd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.