Depression - Major Depressive Disorder
Conditions
Keywords
depression, antidepressant
Brief summary
The goal of this project is to quantify the effectiveness and safety of escitalopram oxalate oral solution in the treatment of first-episode, drug-naïve patients with major depressive disorder, and to explore the mechanisms underlying its antidepressant effects using multi-omics approaches. By integrating clinical, cognitive, laboratory, imaging, genetic, and environmental data, the study aims to identify patient subgroups who are most likely to benefit from escitalopram, thereby promoting individualized and precision treatment for depression. This multicenter, prospective, single-arm intervention study will enroll 200 adults aged 18-65 years with major depressive disorder, who will receive escitalopram oxalate oral solution for 8 weeks. Depressive symptoms, cognitive function, and adverse events will be assessed at baseline, during treatment, and after 8 weeks of treatment to evaluate efficacy and safety. Escitalopram blood concentrations will be measured at week 4 to monitor treatment adherence and support safety evaluation. Through comprehensive data collection and multimodal analysis, this project seeks to clarify the biological mechanisms of escitalopram and provide evidence to guide more precise clinical use of antidepressant therapy.
Interventions
Participants will receive escitalopram oral solution as open-label monotherapy.
Sponsors
Peking University
The First Hospital of Hebei Medical University
First Hospital of China Medical University
Shandong Mental Health Center
Hebei Provincial Mental Health Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-65 years (including 18 and 65), no gender restriction, Han Chinese ethnicity. 2. Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), confirmed by the Mini-International Neuropsychiatric Interview, version 5.0 (MINI). 3. Outpatients or inpatients; Hamilton Depression Rating Scale-17 items (HAMD-17) score ≥17; Hypomania Checklist-32 (HCL-32) score ≤13; and Clinical Global Impressions-Severity (CGI-S) score ≥4. 4. First depressive episode (duration ≤3 months), with no use of antidepressants or other psychotropic medications in the past 3 months. 5. Written informed consent obtained from the patient.
Exclusion criteria
1. Meet DSM-IV diagnostic criteria other mental disorders, including schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive disorder, etc.. 2. Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness; 3. Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury; 4. Have attempted suicide within the past 3 months, or currently present a high suicide risk, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) item 10 score ≥5. 5. Are pregnant or breastfeeding, cannot use reliable contraception during the study, or plan to conceive (or impregnate a partner) within 3 months after study initiation. 6. Have known allergies to escitalopram oxalate or its excipients. 7. Are currently taking medications that may interfere with the evaluation of escitalopram efficacy. 8. Have participated in another drug clinical trial within the past 3 months. 9. Have contraindications to MRI scanning, such as metal implants or claustrophobia. 10. Considered unsuitable for study participation by the investigators for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Hamilton Depression Rating Scale (HAMD) | Week 4 and 8 of treatment duration | The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 24, with higher scores indicating more severe depressive symptoms. The change of HAMD from baseline to 8-week (after intervention) was used as the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lipid biomarkers | Baseline, Week 4, and Week 8 of treatment duration | Change from baseline in total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C). All biomarkers are measured in mmol/L. |
| Change from baseline in fasting blood glucose | Baseline, Week 4, and Week 8 of treatment duration | Change from baseline in fasting blood glucose, measured in mmol/L. |
| Change from baseline in glycated hemoglobin (HbA1c) | Baseline, Week 4, and Week 8 of treatment duration | Change from baseline in glycated hemoglobin (HbA1c), measured as percentage (%). |
| Brain imaging features | Week 0 and 8 of treatment duration | Acquisition was performed by magnetic resonance imaging |
| Change from baseline in Connor-Davidson Resilience Scale (CD-RISC) | Week 4 and 8 of treatment duration | Change from baseline in the Connor-Davidson Resilience Scale (CD-RISC) total score. The total score ranges from 0 to 100 (25-item version). Higher scores indicate greater psychological resilience. |
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | Week 4 and 8 of treatment duration | Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The MADRS consists of 10 clinician-rated items with a total score ranging from 0 to 60. Higher scores indicate more severe depressive symptoms. |
| Response to treatment | Week 4 and 8 of treatment duration | Treatment response is defined as a ≥50% reduction from baseline in either the 17-item Hamilton Depression Rating Scale (HAMD-17) total score or the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. |
| Clinical Global Impression-Severity of Illness (CGI-S) | Baseline; Week 4 and 8 of treatment duration | The Clinical Global Impression-Severity of Illness (CGI-S) scale is a clinician-rated measure of illness severity ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater illness severity. |
| Change from baseline in C-BCT score | Week 4 and 8 of treatment duration | Change from baseline in the Cognitive Bias Questionnaire (C-BCT) T-score. The C-BCT score is standardized as a T-score ranging from 0 to 100. Higher T-scores indicate greater cognitive function. |
| Change from baseline in Hamilton Anxiety Rating Scale (HAMA) | Week 4 and 8 of treatment duration | Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) total score. The HAMA contains 14 items with a total score ranging from 0 to 56. Higher scores indicate more severe anxiety symptoms. |
| Treatment Emergent Symptom Scale (TESS) | Baseline; Week 4 and 8 of treatment duration | The Treatment Emergent Symptom Scale (TESS) is used to assess adverse events during treatment. The total score ranges from 0 to 350 (please specify according to the version used). Higher scores indicate greater severity of treatment-emergent adverse effects. |
| Escitalopram Therapeutic drug monitoring | Week 4 of treatment duration | — |
| Change from baseline in Snaith-Hamilton Pleasure Scale (SHAPS) | Week 4 and 8 of treatment duration | Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score. The SHAPS consists of 14 items with a total score ranging from 0 to 56. Higher scores indicate greater anhedonia. |
| The Temporal Experience of Pleasure Scale (TEPS) | Week 4 and 8 of treatment duration | Change from baseline in the Temporal Experience of Pleasure Scale (TEPS) total score. The score ranges from 0 to 100 depending on the version used. Higher scores indicate greater hedonic capacity. |
| Childhood Trauma Questionnaire (CTQ) | Baseline | The Childhood Trauma Questionnaire (CTQ) assesses childhood maltreatment experiences. The total score ranges from 28 to 140. Higher scores indicate more severe childhood trauma. |
| Change from baseline in Ruminative Responses Scale (RRS) | Week 4 and 8 of treatment duration | Change from baseline in the Ruminative Responses Scale (RRS) total score. The total score ranges from 22 to 88. Higher scores indicate greater rumination. |
| Change from baseline in liver function biomarkers | Baseline, Week 4, and Week 8 of treatment duration | Change from baseline in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Both biomarkers are measured in IU/L. |
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) | Week 4 and 8 of treatment duration | Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score. The total score ranges from 0 to 21. Higher scores indicate poorer sleep quality. |
Countries
China
Contacts
CONTACTWeihua Yue
CONTACTTong Yu
Outcome results
None listed