Selenium plus fluoxetine for depression in teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial evaluating selenium yeast as an addition to fluoxetine in children and adolescents with major depressive disorder. The study will enroll 172 participants aged 12–18 who have a CDRS-R score of 40 or higher and meet DSM-5 criteria, and randomize them 1:1 to receive selenium yeast (60–200 μg/day) or matching placebo alongside fluoxetine (10–60 mg/day, adjusted by clinicians). Participants will undergo biomarker collection (blood, urine, stool) and brain MRI at baseline, week 4, and week 8 to explore mechanisms and potential effects on ferroptosis-related pathways, with outcomes including changes in depressive symptoms (CDRS-R, BDI-II) and secondary measures such as anxiety, overall functioning, mania risk, suicidality, and quality of life. Safety monitoring and routine labs will be conducted throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhou Xinyu
• Email: zhouxinyu@cqmu.edu.cn
• Phone: 15823996993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.