Exploring immune cell markers for predicting antidepressant response in depression

Association of Peripheral Immune Cells With Antidepressant Treatment Response

This study is trying to find out if certain immune cell markers can help predict how well people with depression will respond to antidepressant treatment.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06182722 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify potential biomarkers that can predict how patients with major depressive disorder (MDD) respond to antidepressant treatment. It will compare transcriptomic changes in peripheral immune cells between MDD patients and healthy controls, assessing participants at multiple time points during treatment. The study employs advanced techniques such as single-cell RNA sequencing and flow cytometry to analyze blood samples and validate findings. Participants will undergo mental health assessments and physical examinations throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of major depressive disorder who are currently receiving SSRIs or SNRIs.

Not a fit: Patients with other mental illnesses, serious health conditions, or those taking medications that affect the immune system may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with major depressive disorder.

How similar studies have performed: While the approach of using immune cell biomarkers in depression treatment is gaining interest, this specific study's methodology is relatively novel and has not been extensively tested in prior research.

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 immunosuppressants;
8. Patients who have taken antidepressants or other antipsychotics within 2 weeks before enrollment;
9. Patients who have received MECT or systematic psychotherapy within 3 months before enrollment;
10. Patients at high risk of suicide, or reporting a HAMD-17 item 3 (suicide item) score \>3 at baseline;
11. Subjects who are pregnant or lactating;
12. Other conditions that are considered not suitable for participating in the research.

Where this trial is running

Shanghai, Shanghai

• Shanghai Mental Health Center — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Huangfang Li

Conditions: Depressive Disorder, Genetic Change