NCT07203144 Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study
| NCT ID | NCT07203144 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Chongqing Medical University |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 172 participants in total. It began in 2025-12-31 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 treatment of depression in this population.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07203144 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07203144 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07203144 currently recruiting?
Yes, NCT07203144 is actively recruiting participants. Contact the research team at zhouxinyu@cqmu.edu.cn for enrollment information.
Where is the NCT07203144 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07203144 clinical trial?
NCT07203144 is sponsored by First Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 172 participants.
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