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

NCT07203144

RecruitingPhase 2

Sponsor: First Affiliated Hospital of Chongqing Medical University

Conditions: Depression - Major Depressive Disorder

Interventions: selenium yeast supplementation, Placebo yeast supplementation

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Chongqing, Chongqing Municipality, China