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.
This randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of selenium supplementation (selenium yeast) combined with fluoxetine in children and adolescents with major depressive disorder (MDD). Eligible participants are aged \[specific age range if applicable\], meet DSM-5 criteria for a current depressive episode, and have a CDRS-R score ≥40 confirmed by trained psychiatrists. A total of \[planned sample size\] participants will be randomized 1:1 to receive either fluoxetine plus selenium yeast or fluoxetine plus placebo. Selenium yeast will be administered at 60-200 μg/day. Fluoxetine will begin at 10 mg/day and may be adjusted by the treating psychiatrist within a range of 20-60 mg/day. The placebo consists of commercially available yeast tablets identical in appearance, taste, and size to selenium yeast, administered at 60-200 μg/day. Biological samples (blood, urine, stool) will be collected for routine laboratory tests, thyroid, liver, and kidney function, and serum will be analyzed for selenium and ferroptosis-related biomarkers. Brain MRI will also be performed. These assessments will be repeated at weeks 4 and 8 of treatment, together with rating scale evaluations and biospecimen collection. The primary outcome is the change in depressive symptoms, measured by the CDRS-R and Beck Depression Inventory (BDI). Secondary outcomes include anxiety symptoms (SCARED, HAMA), overall clinical improvement (CGI-S, CGI-I), manic symptoms (YMRS), suicide risk (C-SSRS), quality of life (PedsQL 4.0), sleep quality (PSQI), and rumination (RSS). Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments. This study will provide preliminary evidence on the adjunctive role of selenium supplementation in fluoxetine treatment for adolescent depression and inform future large-scale trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
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.
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.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
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. Primary Outcome Measure is clinical response (≥ 50% reduction in CDRS-R scores from baseline)；
Time frame: Week 4 and Week 8 of treatment
Change in BDI-II (Baker Depression Scale) scores from baseline
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.
Time frame: Week 4 and Week 8 of treatment
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
The SCARED (Screen for Child Anxiety-Related Emotional Disorders) is a self-report scale used to assess anxiety symptoms. The minimum score is 0 and the maximum score is 82, with higher scores indicating more severe anxiety. One of the secondary outcome measures is the improvement in anxiety, represented by the change in the SCARED score compared to the baseline.
Time frame: Week 4 and Week 8 of treatment
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a tool used to assess the risk of self-harm or suicide, and it does not have a score. One of the secondary outcome measures is to evaluate whether there is an improvement in self-harm or suicidal ideation and behavior compared to the baseline.
Time frame: Week 4 and Week 8 of treatment
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
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The PSQI (Pittsburgh Sleep Quality Index) is a self-report scale used to assess sleep quality. The minimum score is 0, and the maximum score is 60. Higher scores indicate poorer sleep quality. One of the secondary outcome measures is to evaluate the change in the PSQI score compared to the baseline, assessing whether sleep treatment has led to improvement.
Time frame: Week 4 and Week 8 of treatment
Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline
The PedsQL 4.0 (The Pediatric Quality of Life Inventory) is a self-report scale used to assess the quality of life in children. The minimum score is 0, and the maximum score is 92. Higher scores indicate better quality of life. One of the secondary outcome measures is the change in the PedsQL score compared to the baseline, assessing whether there has been an improvement in quality of life.
Time frame: Week 4 and Week 8 of treatment
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Improvement in overall clinical impression severity ( 7-point scale, with 1 being normal and 7 being among the most severely damaged )
Time frame: Week 4 and Week 8 of treatment
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Improvement of clinical general Impression scale (7-point scale,7 denoting a very significant deterioration)
Time frame: Week 4 and Week 8 of treatment
Change in RSS (Ruminative Responses Scale)
The level of improvement in negative thinking(The minimum score is 22 and the maximum score is 88; the higher the total score, the more reflective thinking the more severe it is).
Time frame: Week 4 and Week 8 of treatment