Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study
NCT07203144 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172
Last updated 2025-12-29
Summary
The purpose of this study is to investigate the role and mechanisms of selenium in depression among children and adolescents, aiming to provide new insights for understanding the pathogenesis and treatment of depression in this population.
Conditions
- Depression - Major Depressive Disorder
Interventions
- DRUG
-
selenium yeast supplementation
In this intervention, patients will receive adjunctive selenium yeast supplementation at a daily dose of 60-200 μg in addition to fluoxetine. Symptom rating scales, biospecimen collection, and brain MRI will be conducted at baseline, week 4, and week 8 to investigate the adjunctive role of selenium in fluoxetine treatment for depression.
- DRUG
-
Placebo yeast supplementation
In this intervention, patients will receive standard fluoxetine treatment combined with placebo yeast supplementation (60-200 μg/day), which is identical in appearance and odor to selenium yeast. The aim is to clarify the specific role of selenium in the treatment of depression.
Sponsors & Collaborators
-
First Affiliated Hospital of Chongqing Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-31
- Primary Completion
- 2027-04-01
- Completion
- 2027-04-01
Countries
- China
Study Locations
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