Status:
NOT_YET_RECRUITING
Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Conditions:
Depression - Major Depressive Disorder
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
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 trea...
Detailed Description
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 maj...
Eligibility Criteria
Inclusion
- 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 ≥28 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
- 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);
- Aand left-handed individuals.
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT07203144
Start Date
December 31 2025
End Date
April 1 2027
Last Update
December 29 2025
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 40000