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

NCT07203144 | Not Yet Recruiting Phase 2

• 1 other identifier: 1stChongqingMU---ZXY
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

  The Children's Depression Rating Scale-Revised (CDRS-R) has a minimum score of 17 and a maximum score of 113. Higher scores indicate greater severity of depression. Primary Outcome Measure is clinical response (≥ 50% reduction in CDRS-R scores from baseline)；

  Week 4 and Week 8 of treatment

Secondary Outcomes (8)

• Change in BDI-II (Baker Depression Scale) scores from baseline

  Week 4 and Week 8 of treatment

• Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline

  Week 4 and Week 8 of treatment

• Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)

  Week 4 and Week 8 of treatment

• Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline

  Week 4 and Week 8 of treatment

• Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline

  Week 4 and Week 8 of treatment

Study Arms (2)

Fluoxetine combined with selenium yeast therapy

EXPERIMENTAL

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.

Drug: selenium yeast supplementation

Fluoxetine combined with placebo therapy

PLACEBO COMPARATOR

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.

Drug: Placebo yeast supplementation

Interventions

Placebo yeast supplementation DRUG

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.

Fluoxetine combined with placebo therapy

selenium yeast supplementation DRUG

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 selenium yeast therapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 40000, China

Location

Related Publications (16)

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  PMID: 31282938 RESULT

• 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.

  PMID: 25692174 RESULT

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 22381456 RESULT

• 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.

  PMID: 35130906 RESULT

• 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.

  PMID: 36430312 RESULT

• 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.

  PMID: 19399585 RESULT

• 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.

  PMID: 34095192 RESULT

• 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.

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• 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.

  PMID: 29631563 RESULT

• 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.

  PMID: 36442656 RESULT

• 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.

  PMID: 35002238 RESULT

• 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.

  PMID: 24005242 RESULT

Central Study Contacts

Zhou Xinyu

CONTACT

15823996993; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CN (1)