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Recruiting NCT06182722

Association of Peripheral Immune Cells With Antidepressant Treatment Response

Trial Parameters

Condition Depressive Disorder
Sponsor Shanghai Mental Health Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-03-13
Completion 2025-12
Interventions
Mental assessments

Brief Summary

The purpose of this observational study is discovering potential biomarkers to predict antidepressant treatment response in patients with major depressive disorder (MDD) while comparing the transcriptomic changes between patients with MDD and healthy controls as well as before and after antidepressant treatment. Eligible patients will be assessed at Week 1, Week 2, Week 4 and Week 8 while healthy normal volunteers will only be evaluated at baseline. Assessments will include the following: an interview about mental and physical health, a physical examination including drawing of venous blood samples and several psychiatric rating scales.

Eligibility Criteria

Inclusion Criteria: 1. Age 18-65 years old, regardless of gender; 2. The subject is an outpatient/inpatient and meets DSM-5 diagnostic criteria of current or past major depressive disorder; 3. SSRIs or SNRIs monotherapy; 4. HAMD-17 total score ≥ 18 at baseline; 5. The subject can read and write and is capable of giving informed consent. Exclusion Criteria: 1. Patients with mental illness other than MDD; 2. Patients with liver and kidney diseases, cardiovascular system diseases, cancer, diabetes, thyroid diseases or other serious or unstable conditions; 3. Previous organic brain disease, traumatic brain injury or other diseases that can cause structural brain changes; 4. Serious abnormalities indicated by laboratory tests or electrocardiograms; 5. Alcohol or drug addiction; 6. Suffering from systemic lupus erythematosus, multiple sclerosis or other autoimmune diseases; 7. Patients who are taking drugs that directly impact on the immune system such as anti-inflammatory drugs or immunosup

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