Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study
NCT ID: NCT07203144
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
172 participants
INTERVENTIONAL
2025-12-31
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fluoxetine combined with selenium yeast therapy
In this group, participants will receive standard fluoxetine treatment along with adjunctive selenium yeast supplementation at a daily dose of 60-200 μg, aiming to investigate the role and mechanisms of selenium yeast in fluoxetine therapy.
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.
Fluoxetine combined with placebo therapy
Participants in this group, in addition to receiving conventional fluoxetine treatment, were administered 60-200 µg per day of a placebo identical in appearance and odor to selenium yeast as adjunctive therapy. The aim was to investigate the role of selenium yeast in fluoxetine treatment and to clarify whether it enhances the therapeutic effect.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
12 Years
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Xinyu Zhou
professor
Locations
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhou Xinyu
Role: primary
References
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Barker MM, Beresford B, Bland M, Fraser LK. Prevalence and Incidence of Anxiety and Depression Among Children, Adolescents, and Young Adults With Life-Limiting Conditions: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Sep 1;173(9):835-844. doi: 10.1001/jamapediatrics.2019.1712.
Hankin BL. Depression from childhood through adolescence: Risk mechanisms across multiple systems and levels of analysis. Curr Opin Psychol. 2015 Aug;4:13-20. doi: 10.1016/j.copsyc.2015.01.003.
Consoli A, Peyre H, Speranza M, Hassler C, Falissard B, Touchette E, Cohen D, Moro MR, Revah-Levy A. Suicidal behaviors in depressed adolescents: role of perceived relationships in the family. Child Adolesc Psychiatry Ment Health. 2013 Mar 16;7(1):8. doi: 10.1186/1753-2000-7-8.
Dolle K, Schulte-Korne G. The treatment of depressive disorders in children and adolescents. Dtsch Arztebl Int. 2013 Dec 13;110(50):854-60. doi: 10.3238/arztebl.2013.0854.
Cipriani A, Zhou X, Del Giovane C, Hetrick SE, Qin B, Whittington C, Coghill D, Zhang Y, Hazell P, Leucht S, Cuijpers P, Pu J, Cohen D, Ravindran AV, Liu Y, Michael KD, Yang L, Liu L, Xie P. Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis. Lancet. 2016 Aug 27;388(10047):881-90. doi: 10.1016/S0140-6736(16)30385-3. Epub 2016 Jun 8.
Kryukov GV, Castellano S, Novoselov SV, Lobanov AV, Zehtab O, Guigo R, Gladyshev VN. Characterization of mammalian selenoproteomes. Science. 2003 May 30;300(5624):1439-43. doi: 10.1126/science.1083516.
Rayman MP. Selenium and human health. Lancet. 2012 Mar 31;379(9822):1256-68. doi: 10.1016/S0140-6736(11)61452-9. Epub 2012 Feb 29.
Dang R, Wang M, Li X, Wang H, Liu L, Wu Q, Zhao J, Ji P, Zhong L, Licinio J, Xie P. Edaravone ameliorates depressive and anxiety-like behaviors via Sirt1/Nrf2/HO-1/Gpx4 pathway. J Neuroinflammation. 2022 Feb 7;19(1):41. doi: 10.1186/s12974-022-02400-6.
Xu C, Xiong Q, Tian X, Liu W, Sun B, Ru Q, Shu X. Alcohol Exposure Induces Depressive and Anxiety-like Behaviors via Activating Ferroptosis in Mice. Int J Mol Sci. 2022 Nov 10;23(22):13828. doi: 10.3390/ijms232213828.
Reeves MA, Hoffmann PR. The human selenoproteome: recent insights into functions and regulation. Cell Mol Life Sci. 2009 Aug;66(15):2457-78. doi: 10.1007/s00018-009-0032-4. Epub 2009 Apr 28.
Ferreira de Almeida TL, Petarli GB, Cattafesta M, Zandonade E, Bezerra OMPA, Tristao KG, Salaroli LB. Association of Selenium Intake and Development of Depression in Brazilian Farmers. Front Nutr. 2021 May 20;8:671377. doi: 10.3389/fnut.2021.671377. eCollection 2021.
Mokhber N, Namjoo M, Tara F, Boskabadi H, Rayman MP, Ghayour-Mobarhan M, Sahebkar A, Majdi MR, Tavallaie S, Azimi-Nezhad M, Shakeri MT, Nematy M, Oladi M, Mohammadi M, Ferns G. Effect of supplementation with selenium on postpartum depression: a randomized double-blind placebo-controlled trial. J Matern Fetal Neonatal Med. 2011 Jan;24(1):104-8. doi: 10.3109/14767058.2010.482598. Epub 2010 Jun 8.
Islam MR, Islam MR, Shalahuddin Qusar MMA, Islam MS, Kabir MH, Mustafizur Rahman GKM, Islam MS, Hasnat A. Alterations of serum macro-minerals and trace elements are associated with major depressive disorder: a case-control study. BMC Psychiatry. 2018 Apr 10;18(1):94. doi: 10.1186/s12888-018-1685-z.
Wang H, Jin M, Xie M, Yang Y, Xue F, Li W, Zhang M, Li Z, Li X, Jia N, Liu Y, Cui X, Hu G, Dong L, Wang G, Yu Q. Protective role of antioxidant supplementation for depression and anxiety: A meta-analysis of randomized clinical trials. J Affect Disord. 2023 Feb 15;323:264-279. doi: 10.1016/j.jad.2022.11.072. Epub 2022 Nov 25.
Albrakati A, Alsharif KF, Al Omairi NE, Alsanie WF, Almalki ASA, Abd Elmageed ZY, Elshopakey GE, Lokman MS, Bauomy AA, Abdel Moneim AE, Kassab RB. Neuroprotective Efficiency of Prodigiosins Conjugated with Selenium Nanoparticles in Rats Exposed to Chronic Unpredictable Mild Stress is Mediated Through Antioxidative, Anti-Inflammatory, Anti-Apoptotic, and Neuromodulatory Activities. Int J Nanomedicine. 2021 Dec 30;16:8447-8464. doi: 10.2147/IJN.S323436. eCollection 2021.
Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.
Other Identifiers
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1stChongqingMU---ZXY
Identifier Type: -
Identifier Source: org_study_id