Recruiting
Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study
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.
ClinicalTrials.gov IDNCT07203144
PhasePHASE2
Enrollment172
SponsorFirst Affiliated Hospital of Chongqing Medical University
Age12 Years
SexALL
Conditions studied
Depression - Major Depressive Disorder
About this study
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.
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.
Primary outcomes
- Change in CDRS-R (Children's Depression Rating Scale) scores from baseline (Baseline, Week 4 and Week 8 of treatment)
- Change in BDI-II (Beck Depression Inventory-II) scores from baseline (Baseline, Week 4 and Week 8 of treatment)
Eligibility information
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.
Study locations
- The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality 40000 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.