Treatment-resistant depression (defined as failure to respond to at least two adequate antidepressant trials at the maximum tolerated dose, each lasting >=6 weeks)
Conditions
Interventions
Intervention group:Two intervention treatments will be administered at Day 0 + 3 days and Day 7 + 3 days (with an interval of approximately 1 week between the two interventions). Participants in the e
Control group:Two intervention treatments will be administered at Day 0 + 3 days and Day 7 + 3 days (with an interval of approximately 1 week between the two interventions). On the basis of maintainin
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Outpatient or inpatient, aged 18–50 years (inclusive of both 18 and 50 years), regardless of gender; 2. Current episode meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder; 3. Score of >= 24 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 4. Treatment-resistant depression (defined as inadequate response to at least two adequate trials of different antidepressants at maximum tolerated doses for >= 6 weeks during the current illness episode); 5. Educational level of at least elementary school graduation, capable of understanding the content of assessment scales; 6. Stable dose of current antidepressant medication for at least 4 weeks; 7. Patient has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Current or past diagnosis, according to DSM-5 criteria, of bipolar disorder, neurodevelopmental disorders, neurocognitive disorders, schizophrenia spectrum and other psychotic disorders, or substance-related and addictive disorders; 2. Presence of any of the following medical conditions or treatments that may affect patient safety: (1) Significant history or current evidence of cardiovascular disease, including heart failure (NYHA functional class II–IV), myocardial infarction within 6 months, unstable angina within 6 months, transient ischemic attack (TIA) within 6 months, stroke, clinically significant arrhythmias requiring treatment, or uncontrolled hypertension; (2) Screening electrocardiogram (ECG) showing clinically significant arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker); (3) Personal or family history of congenital long QT syndrome or known familial history of torsades de pointes; (4) Severe respiratory disease history or current condition (e.g., chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis); (5) Asthma requiring regular oral corticosteroid therapy; (6) Severe hepatic impairment (Child-Pugh class C) or chronic hepatic or biliary disease; (7) Severe renal impairment (glomerular filtration rate = 3 on the suicide item of the HAMD-17; 4. Use of immunosuppressants or anti-inflammatory medications within the past 1 month; 5. Pregnant or breastfeeding women, and women of childbearing potential whose themselves or their spouse/partner plan to become pregnant within the next 6 months, must be excluded; 6. History of severe hypersensitivity to ofatumumab or any of its components; 7. Presence of malignant tumors; 8. Active hepatitis B virus infection (which may lead to reactivation and risk of liver failure); known hepatitis B virus carriers (requiring prophylactic antiviral therapy); 9. Severe immunodeficiency or uncontrolled systemic infection (e.g., sepsis, active tuberculosis); 10. Laboratory abnormalities prior to randomization: (1) Total or direct bilirubin > 1.5 × upper limit of normal (ULN) (Gilbert’s syndrome excluded); (2) Alkaline phosphatase > 1.5 × ULN; (3) AST or ALT > 1.5 × ULN, or gamma-glutamyl transferase (GGT) > 2 × ULN; (4) White blood cell count < 3500/mm^3 (< 3.5 × 10^9/L); (5) Lymphocyte count < 800/mm^3 (< 0.8 × 10^9/L); (6) Serum IgG and/or IgM below the lower limit of normal (as per central laboratory reference ranges); (7) Other clinically significant laboratory abnormalities as determined by the investigator (e.g., severe anemia, neutropenia, thrombocytopenia, or signs of bone marrow dysfunction).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction in HAMD-17 scores from baseline at week 8 between the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in PSQI subscale scores from baseline at each follow-up visit;Differences in score reductions on the HAMD-17 scale across four symptom dimensions at each follow-up visit: Depression (items 1/2/3/7/8) Anxiety (items 9/10/11/15/17) Insomnia (items 4/5/6) Somat;Change in QIDS-SR-16 total scores from baseline at each follow-up visit;Changes in FIBSER scale scores (symptoms and severity) at each follow-up visit;Change in SF-12 total scores from baseline at each follow-up visit;Abnormalities in vital signs, laboratory tests, and ECG during the study, as well as reports of adverse events and adverse reactions;Difference in the proportion of patients with =50% reduction in MADRS total scores from baseline at week 8 between the two groups;Difference in complete remission rates (HAMD-17 =7) between the two groups at week 8;Peripheral blood cytokine levels (e.g., IL-6, TNF-a, IL-10, IFN-?) at baseline, week 2, and week 8;Change in GAD-7 total scores from baseline at each follow-up visit;Changes in immune cell subsets (e.g., T cells, B cells, monocyte proportions, and activation markers) at baseline, week 2, and week 8;Difference in MADRS <12 between the two groups at week 8;Changes in CGI subscale scores from baseline at each follow-up visit;Change in SDS total scores from baseline at each follow-up visit; | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed