selenium yeast supplementation / Depression Major Depressive Disorder / Placebo yeast supplementation · Phase 2 Trial

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration evaluating selenium yeast supplementation versus placebo for major depressive disorder in children and adolescents. No results are yet reported in this registry record; the study remains in recruitment and is designed to investigate both efficacy and mechanistic pathways.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Depression - Major Depressive Disorder; age from 12 Years; to 18 Years. Intervention: Fluoxetine combined with selenium yeast therapy. Compared with: Fluoxetine combined with placebo therapy — Placebo Comparator. n = 172. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 interventional trial still recruiting with no results posted; it is early-stage work designed to explore mechanistic pathways rather than confirm efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in CDRS-R (Children's Depression Rating Scale) scores from baseline (assessed at Baseline, Week 4 and Week 8 of treatment); Change in BDI-II (Baker Depression Scale) scores from baseline (assessed at Baseline, Week 4 and Week 8 of treatment)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationDepression - Major Depressive Disorder; age from 12 Years; to 18 Years

Sample size172

InterventionFluoxetine combined with selenium yeast therapy

ComparatorFluoxetine combined with placebo therapy — Placebo Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment172

PhasePhase 2

Primary outcome measure 1Change in CDRS-R scores from baseline at Week 4 and Week 8

Primary outcome measure 2Change in BDI-II scores from baseline at Week 4 and Week 8

Caveats

No results reported in this registry record; study is still recruiting.
Phase 2 design limits generalizability; efficacy confirmation would require Phase 3 trial.
Mechanistic endpoints and their specific measures are not detailed in registry record.
Long-term follow-up duration not specified; treatment period appears limited to 8 weeks.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective interventional trial with placebo comparator and defined primary endpoints.

Directness

strong

Measures clinical depression outcomes directly in the target population via validated scales.

Consistency

insufficient

Registry record only; no results reported to assess consistency with prior work.

Risk of bias

insufficient

Blinding and allocation concealment methods not described in registry record.

Sample adequacy

moderate

Planned enrollment 172 participants; adequate for Phase 2 mechanistic exploration.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07203144). This is a study registration, not published results. Lead sponsor: First Affiliated Hospital of Chongqing Medical University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 172 participants (ESTIMATED). Conditions: Depression - Major Depressive Disorder. Interventions: DRUG: selenium yeast supplementation; DRUG: Placebo yeast supplementation. Primary outcome measures: Change in CDRS-R (Children's Depression Rating Scale) scores from baseline , Baseline, Week 4 and Week 8 of treatment; Change in BDI-II (Baker Depression Scale) scores from baseline , Baseline, Week 4 and Week 8 of treatment. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

selenium yeast supplementationDepression Major Depressive DisorderNCT07203144Placebo yeast supplementationFirst Affiliated Hospital of Chongqing Medical University