Depression - Major Depressive Disorder
Conditions
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.
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.
Interventions
DRUGselenium 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.
DRUGPlacebo 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.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CDRS-R (Children's Depression Rating Scale) scores from baseline | Baseline, Week 4 and Week 8 of treatment | 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； |
| Change in BDI-II (Beck Depression Inventory-II) scores from baseline | Baseline, Week 4 and Week 8 of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline | Baseline, Week 4 and Week 8 of treatment | 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. |
| Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline | Baseline, Week 4 and Week 8 of treatment | 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. |
| Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale) | Baseline, Week 4 and Week 8 of treatment | 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. |
| Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline | Baseline, Week 4 and Week 8 of treatment | 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. |
| Change in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores from baseline | Baseline, Week 4 and Week 8 of treatment | 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. |
| Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline | Baseline, Week 4 and Week 8 of treatment | Improvement in overall clinical impression severity ( 7-point scale, with 1 being normal and 7 being among the most severely damaged ) |
| Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline | Week 4 and Week 8 of treatment | Improvement of clinical general Impression scale (7-point scale,7 denoting a very significant deterioration) |
| Change in RRS (Ruminative Responses Scale) | Baseline, Week 4 and Week 8 of treatment | 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). |
| Change in Young Mania Rating Scale (YMRS) | Week 4 and Week 8 of treatment | 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. |
Countries
China
Contacts
CONTACTZhou Xinyu
Outcome results
None listed