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Depression - Major Depressive DisorderPhase 2NCT07203144

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

A Phase 2 study testing selenium yeast supplementation in people with Depression - Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Depression - Major Depressive Disorder
What is being tested?
selenium yeast supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
1 siteChina
Study dates
31 Dec 2025to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 40000

    Zhou Xinyu, 15823996993, zhouxinyu@cqmu.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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 major depressive disorder (MDD). Eligible participants are aged 12-18 years, meet DSM-5 criteria for a current depressive episode, and have a CDRS-R score ≥40 confirmed by trained psychiatrists. A total of 172 participants will be randomized 1:1 to receive either fluoxetine plus selenium yeast or fluoxetine plus placebo. Selenium yeast will be administered at 60-200 μg/day. Fluoxetine will begin at 10 mg/day and may be adjusted by the treating psychiatrist within a range of 20-60 mg/day. The placebo consists of commercially available yeast tablets identical in appearance, taste, and size to selenium yeast, administered at 60-200 μg/day. Biological samples (blood, urine, stool) will be collected for routine laboratory tests, thyroid, liver, and kidney function, and serum will be analyzed for selenium and ferroptosis-related biomarkers. Brain MRI will also be performed. These assessments will be repeated at weeks 4 and 8 of treatment, together with rating scale evaluations and biospecimen collection. The primary outcome is the change in depressive symptoms, measured by the CDRS-R and Beck Depression Inventory-II (BDI-II). Secondary outcomes include anxiety symptoms (SCARED, HAMA), overall clinical improvement (CGI-S, CGI-I), manic symptoms (YMRS), suicide risk (C-SSRS), quality of life (PedsQL 4.0), sleep quality (PSQI), and rumination (RRS). Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments. This study will provide preliminary evidence on the adjunctive role of selenium supplementation in fluoxetine treatment for adolescent depression and inform future large-scale trials.

Being tested
selenium yeast supplementation, Placebo yeast supplementation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • selenium yeast supplementationDrug

    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 supplementationDrug

    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.

Study groups in NCT07203144
Study groupRoleWhat they receive
Fluoxetine combined with selenium yeast therapyExperimentalIn 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.
Receives: Drug: selenium yeast supplementation
Fluoxetine combined with placebo therapyPlacebo comparatorParticipants 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.
Receives: Drug: Placebo yeast supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    The primary outcome measures are the response and remission rates of depressive symptoms. Treatment response is defined as a ≥50% reduction in the CDRS-R total score from baseline, whereas remission is defined as a CDRS-R total score ≤28;

    Measured: Baseline, Week 4 and Week 8 of treatment

  2. Change in BDI-II (Beck Depression Inventory-II) scores from baseline

    The BDI-II (Beck Depression Inventory-II) is a self-report scale for assessing depression, with a minimum score of 0 and a maximum score of 63. Higher scores indicate more severe depression. One of the secondary outcome measures is the change in the BDI-II score compared to the baseline.

    Measured: Baseline, Week 4 and Week 8 of treatment

Secondary outcomes (9)
  1. Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline

    The SCARED (Screen for Child Anxiety-Related Emotional Disorders) is a self-report scale used to assess anxiety symptoms. The minimum score is 0 and the maximum score is 82, with higher scores indicating more severe anxiety. One of the secondary outcome measures is the improvement in anxiety, represented by the change in the SCARED score compared to the baseline.

    Measured: Baseline, Week 4 and Week 8 of treatment

  2. Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline

    HAMA comprises 14 items assessing the severity of anxiety symptoms across two domains: psychic anxiety and somatic anxiety. Each item is rated on a 5-point scale ranging from 0 to 4, yielding a total score of 0-56, with higher scores indicating greater severity of anxiety symptoms.

    Measured: Baseline, Week 4 and Week 8 of treatment

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

    The Columbia Suicide Severity Rating Scale (C-SSRS) is a tool used to assess the risk of self-harm or suicide, and it does not have a score. One of the secondary outcome measures is to evaluate whether there is an improvement in self-harm or suicidal ideation and behavior compared to the baseline.

    Measured: Baseline, Week 4 and Week 8 of treatment

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

    The PSQI (Pittsburgh Sleep Quality Index) is a self-report scale used to assess sleep quality. The minimum score is 0, and the maximum score is 60. Higher scores indicate poorer sleep quality. One of the secondary outcome measures is to evaluate the change in the PSQI score compared to the baseline, assessing whether sleep treatment has led to improvement.

    Measured: Baseline, Week 4 and Week 8 of treatment

  5. Change in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores from baseline

    The PedsQL 4.0 (The Pediatric Quality of Life Inventory 4.0) is a self-report scale used to assess the quality of life in children. The minimum score is 0, and the maximum score is 92. Higher scores indicate better quality of life. One of the secondary outcome measures is the change in the PedsQL score compared to the baseline, assessing whether there has been an improvement in quality of life.

    Measured: Baseline, Week 4 and Week 8 of treatment

  6. Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline

    Improvement in overall clinical impression severity ( 7-point scale, with 1 being normal and 7 being among the most severely damaged )

    Measured: Baseline, Week 4 and Week 8 of treatment

  7. Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline

    Improvement of clinical general Impression scale (7-point scale,7 denoting a very significant deterioration)

    Measured: Week 4 and Week 8 of treatment

  8. Change in RRS (Ruminative Responses Scale)

    The level of improvement in negative thinking(The minimum score is 22 and the maximum score is 88; the higher the total score, the more reflective thinking the more severe it is).

    Measured: Baseline, Week 4 and Week 8 of treatment

  9. Change in Young Mania Rating Scale (YMRS)

    The YMRS is a widely used clinician-rated scale for quantifying the severity of manic symptoms in patients with bipolar disorder. It comprises 11 items and yields a total score ranging from 0 to 60, with higher scores indicating greater severity of manic symptoms.

    Measured: Week 4 and Week 8 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start31 Dec 2025
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07203144
Sponsor's protocol ID
1stChongqingMU---ZXY
Status last verified
Aug 2026
First submitted
24 Sep 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31282938
  • 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.

    PubMed 25692174
  • 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.

    PubMed 23497551
  • 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.

    PubMed 24399027
  • 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.

    PubMed 27289172
  • 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.

    PubMed 12775843
  • 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.

    PubMed 22381456
  • 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.

    PubMed 35130906
  • 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.

    PubMed 36430312
  • 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.

    PubMed 19399585
  • 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.

    PubMed 34095192
  • 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.

    PubMed 20528216
  • 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.

    PubMed 29631563
  • 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.

    PubMed 36442656
  • 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.

    PubMed 35002238

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing selenium yeast supplementation in people with Depression - Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhou Xinyu (15823996993, zhouxinyu@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline (time frame: Baseline, Week 4 and Week 8 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203144, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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