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.
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;
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;
Parallel
selenium yeast supplementation
DrugIn 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
DrugIn 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.
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. 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
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.
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.
Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline
HAMA comprises 14 items assessing the severity of anxiety symptoms across two domains: psychic anxiety and somatic anxiety. Each item is rated on a 5-point scale ranging from 0 to 4, yielding a total score of 0-56, with higher scores indicating greater severity of anxiety symptoms.
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.
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
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.
Click on the lead sponsor to view all of their trials.
