Depression - Major Depressive DisorderNCT07480525
Efficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder
A study testing Escitalopram (Oral antidepressant) in people with Depression - Major Depressive Disorder, run by Peking University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Escitalopram (Oral antidepressant)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 20 Mar 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years (including 18 and 65), no gender restriction, Han Chinese ethnicity.
- 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).
- 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.
- First depressive episode (duration ≤3 months), with no use of antidepressants or other psychotropic medications in the past 3 months.
- Written informed consent obtained from the patient.
Who cannot join
- Meet DSM-IV diagnostic criteria other mental disorders, including schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive disorder, etc..
- 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;
- 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;
- 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.
- 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.
- Have known allergies to escitalopram oxalate or its excipients.
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- Are currently taking medications that may interfere with the evaluation of escitalopram efficacy.
- Have participated in another drug clinical trial within the past 3 months.
- Have contraindications to MRI scanning, such as metal implants or claustrophobia.
- Considered unsuitable for study participation by the investigators for any other reason.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Hebei Provincial Mental Health Center
Baoding, Hebei, 071000
Yunshu Zhang, +86 15533222271, yunshucoffee@sina.com
- Recruiting
Peking University Sixth Hostipal
Beijing, Beijing Municipality, 100191
Weihua Yue, 010-82805307, dryue@bjmu.edu.cn
Tong Yu, 010-82805307, tongyu@bjmu.edu.cn
- Recruiting
Shandong Mental Health Center
Jinan, Shandong, 250014
Yuandong Gong, 0531-86336687, 525882199@qq.com
Yuanyuan Dai, 0531-86336621, 412882716@qq.com
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Gang Zhu, +86 13940252095, gzhu@cmu.edu.cn
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
Xueyi Wang, 0311-87155488, ydyywxy@163.com
About this study
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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Escitalopram (Oral antidepressant)
- Keywords
- depression, antidepressant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram (Oral antidepressant)Drug
Participants will receive escitalopram oral solution as open-label monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Participants will receive escitalopram oral solution as open-label monotherapy. Receives: Drug: Escitalopram (Oral antidepressant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Rating Scale (HAMD)
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.
Measured: Week 4 and 8 of treatment duration
Secondary outcomes (18)
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
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.
Measured: Week 4 and 8 of treatment duration
Response to treatment
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.
Measured: Week 4 and 8 of treatment duration
Clinical Global Impression-Severity of Illness (CGI-S)
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.
Measured: Baseline; Week 4 and 8 of treatment duration
Change from baseline in C-BCT score
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.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)
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.
Measured: Week 4 and 8 of treatment duration
Treatment Emergent Symptom Scale (TESS)
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.
Measured: Baseline; Week 4 and 8 of treatment duration
Escitalopram Therapeutic drug monitoring
Measured: Week 4 of treatment duration
Change from baseline in Snaith-Hamilton Pleasure Scale (SHAPS)
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.
Measured: Week 4 and 8 of treatment duration
The Temporal Experience of Pleasure Scale (TEPS)
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.
Measured: Week 4 and 8 of treatment duration
Childhood Trauma Questionnaire (CTQ)
The Childhood Trauma Questionnaire (CTQ) assesses childhood maltreatment experiences. The total score ranges from 28 to 140. Higher scores indicate more severe childhood trauma.
Measured: Baseline
Change from baseline in Ruminative Responses Scale (RRS)
Change from baseline in the Ruminative Responses Scale (RRS) total score. The total score ranges from 22 to 88. Higher scores indicate greater rumination.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)
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.
Measured: Week 4 and 8 of treatment duration
Brain imaging features
Acquisition was performed by magnetic resonance imaging
Measured: Week 0 and 8 of treatment duration
Change from baseline in liver function biomarkers
Change from baseline in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Both biomarkers are measured in IU/L.
Measured: Baseline, Week 4, and Week 8 of treatment duration
Change from baseline in lipid biomarkers
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.
Measured: Baseline, Week 4, and Week 8 of treatment duration
Change from baseline in fasting blood glucose
Change from baseline in fasting blood glucose, measured in mmol/L.
Measured: Baseline, Week 4, and Week 8 of treatment duration
Change from baseline in glycated hemoglobin (HbA1c)
Change from baseline in glycated hemoglobin (HbA1c), measured as percentage (%).
Measured: Baseline, Week 4, and Week 8 of treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start20 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Hebei Medical University, First Hospital of China Medical University, Shandong Mental Health Center, Hebei Provincial Mental Health Center
- Responsible party
- Principal investigator, Weihua Yue, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480525
- Sponsor's protocol ID
- 2025-109
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No