Status:
RECRUITING
Association of Peripheral Immune Cells With Antidepressant Treatment Response
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Depressive Disorder
Genetic Change
Eligibility:
All Genders
18-65 years
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 transcript...
Detailed Description
This study is focusing on evaluating the peripheral immune system of major depressive disorder (MDD) and the impact of antidepressants treatment. Single-cell RNA sequencing and single-cell VDJ sequenc...
Eligibility Criteria
Inclusion
- Age 18-65 years old, regardless of gender;
- The subject is an outpatient/inpatient and meets DSM-5 diagnostic criteria of current or past major depressive disorder;
- SSRIs or SNRIs monotherapy;
- HAMD-17 total score ≥ 18 at baseline;
- The subject can read and write and is capable of giving informed consent.
Exclusion
- Patients with mental illness other than MDD;
- Patients with liver and kidney diseases, cardiovascular system diseases, cancer, diabetes, thyroid diseases or other serious or unstable conditions;
- Previous organic brain disease, traumatic brain injury or other diseases that can cause structural brain changes;
- Serious abnormalities indicated by laboratory tests or electrocardiograms;
- Alcohol or drug addiction;
- Suffering from systemic lupus erythematosus, multiple sclerosis or other autoimmune diseases;
- Patients who are taking drugs that directly impact on the immune system such as anti-inflammatory drugs or immunosuppressants;
- Patients who have taken antidepressants or other antipsychotics within 2 weeks before enrollment;
- Patients who have received MECT or systematic psychotherapy within 3 months before enrollment;
- Patients at high risk of suicide, or reporting a HAMD-17 item 3 (suicide item) score \>3 at baseline;
- Subjects who are pregnant or lactating;
- Other conditions that are considered not suitable for participating in the research.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06182722
Start Date
March 13 2024
End Date
December 1 2025
Last Update
April 9 2024
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030