Actively Recruiting
Probiotic Administration for Adolescent Depression
Led by University of California, San Francisco · Updated on 2025-06-06
77
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.
CONDITIONS
Official Title
Probiotic Administration for Adolescent Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male participants 15 to 24 years of age
- Fluency in English
- Access to smartphone, tablet, or computer capable of running Zoom for remote visits
- Diagnosed with a primary DSM-5 clinical depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder, or Other Specified Depressive Disorder)
- Diagnosis confirmed by K-SADS-COMP if under 18 or SCID-V if 18 or older
- Under the care of a primary care clinician and/or mental health professional
- Currently on SSRI treatment for at least 8 weeks
- Beck Depression Inventory-II (BDI-II) score greater than 13
You will not qualify if you...
- Current diagnosis of other DSM-5 mental health disorders except anxiety disorders and ADHD if depression is primary
- Medically treated with stimulant medication for ADHD unless dosage is stable for at least 8 weeks
- Current diagnosis of any Axis II personality disorder
- Oral probiotic use within 1 month prior to screening
- Oral or IV antibiotic use within 1 month prior to screening
- Consumption of fermented foods (e.g., yogurt, kombucha) within 1 month prior to screening
- Oral antioxidant or omega 3 supplements within 6 weeks prior to screening
- Alcohol intake greater than 2 drinks per week
- Smoking cigarettes more than 5 times in the last 6 months or tobacco use (pipe or hookah at least once in last month)
- Plans to make significant changes in diet and lifestyle
- Immunocompromised status
- Allergies to milk, soy, or yeast
- Tanner Stage less than 3
- Active suicidal ideation requiring hospitalization or with plan/intent
- Suicide attempt within past 6 months requiring hospitalization or emergency care
- History of failure to respond to 2 or more adequate trials of different first-line SSRI medications
- Contraindications to MRI (e.g., braces)
- Pregnancy or plans to become pregnant during the study; women must use approved contraception methods until second MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCSF
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
C
Cherry Leung, PhD, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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