Association of Peripheral Immune Cells With Antidepressant Treatment Response

Recruiting

• Conditions: Depressive Disorder; Genetic Change
• Interventions: Diagnostic Test: Mental assessments

• Registration Number: NCT06182722
• Lead Sponsor: Shanghai Mental Health Center

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.

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 sequencing will be performed on peripheral blood mononuclear cells to collect transcriptome information and immune repertoire of peripheral blood in patients with MDD. Bulk RNA sequencing and flow cytometry will be used to validate the clinical value of results.

This is a biomarker study (antidepressants); treatment will be carried out according to physicians' orders.

Study Timeline

• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-12-25
• Study First Posted: 2023-12-27
• Study Start: 2024-03-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major Depressive Disorder (MDD)	Mental assessments	Patients with major depressive disorder. These patients consisted of two cohorts. The first cohort is expected to consist of 15 participants for nested cohort study. The rest form the second cohort.

Primary Outcome Measures

Name	Time	Method
Change of HAMD-17 (Hamilton Depression Rating Scale) total score	From baseline to Week 8	The overall score of HAMD-17 (Hamilton Depression Rating Scale) is 68 points. Primary outcome measures the change of HAMD-17 total score between baseline and week 8. Larger reduction in HAMD-17 represents better antidepressant treatment response.

Secondary Outcome Measures

Name	Time	Method
MADRS Remission rate measured by MADRS (Montgomery-Åsberg depression rating scale)	From baseline to Week 8	MADRS (Montgomery-Åsberg depression rating scale) total score ≤7 at week8. Lower total score of HAMD-17 at week 8 indicates better outcome. Minimun value of MADRS is 0 and maximum value of MADRS is 60 points.
Effective rate measured by HAMD-17 (Hamilton Depression Rating Scale)	From baseline to Week 8	A reduction of 50% or more in the HAMD-17 (Hamilton Depression Rating Scale) total score. More patients with a reduction of 50% or more indicates better effectiveness. Minimun value of HAMD-17 is 0 and maximum value of HAMD-17 is 68 points.
Remission rate measured by HAMD-17 (Hamilton Depression Rating Scale)	From baseline to Week 8	HAMD-17 (Hamilton Depression Rating Scale) total score ≤10 at week8. Lower total score of HAMD-17 at week 8 indicates better outcome. Minimun value of HAMD-17 is 0 and maximum value of HAMD-17 is 68 points.
MADRS Effective rate measured by MADRS (Montgomery-Åsberg depression rating scale)	From baseline to Week 8	A reduction of 50% or more in the MADRS (Montgomery-Åsberg depression rating scale) total score. More patients with a reduction of 50% or more indicates better effectiveness. Minimun value of MADRS is 0 and maximum value of MADRS is 60 points.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China