Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study

NCT07203144 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Chongqing Medical University

Phase

Phase 2

Started

2025-12-31

Last updated

2026-08-31

Condition(s) studied

Depression - Major Depressive Disorder

Investigational drug(s) / intervention(s)

selenium yeast supplementationPlacebo yeast supplementation

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

18 Years

Healthy volunteers

Inclusion Criteria: * Aged 12-18 years; * Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), using the K-SADS-PL diagnostic tool; * A score of ≥40 on the Children's Depression Rating Scale-Revised (CDRS-R); * Adequate visual and auditory abilities to complete the study; * Willingness to participate in the study with informed consent signed by both the participant and a legal guardian. Exclusion Criteria: * Patients with severe psychiatric disorders such as bipolar disorder, schizophrenia, bulimia nervosa, anorexia nervosa, or primary obsessive-compulsive disorder; * Those with severe physical illnesses or other life-threatening conditions; patients in a current depressive episode with a clear suicidal plan or history of suicide attempt; * Individuals with a history of substance or drug abuse; * Those requiring immediate hospitalization for psychiatric disorders; * Patients currently taking medications contraindicated with the investigational drug or that may interfere with its efficacy; * Those who have received modified electroconvulsive therapy (MECT) within the past 12 months; * Individuals allergic to selenium yeast protein, including those with allergic rhinitis, gastrointestinal sensitivity, allergic constitution, or autoimmune diseases such as Graves' disease or Hashimoto's thyroiditis; * Patients with contraindications to magnetic resonance imaging (MRI); * Left-handed individuals.

Primary outcome measure(s)

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline — Baseline, Week 4 and Week 8 of treatment
The Children's Depression Rating Scale-Revised (CDRS-R) has a minimum score of 17 and a maximum score of 113. Higher scores indicate greater severity of depression. The primary outcome measures are the response and remission rates of depressive symptoms. Treatment response is defined as a ≥50% reduction in the CDRS-R total score from baseline, whereas remission is defined as a CDRS-R total score ≤28；
Change in BDI-II (Beck Depression Inventory-II) scores from baseline — Baseline, Week 4 and Week 8 of treatment
The BDI-II (Beck Depression Inventory-II) is a self-report scale for assessing depression, with a minimum score of 0 and a maximum score of 63. Higher scores indicate more severe depression. One of the secondary outcome measures is the change in the BDI-II score compared to the baseline.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07203144 on ClinicalTrials.gov ↗ ← All trials in China