Efficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder

NCT07480525 | Not Yet Recruiting

• 1 other identifier: 2025-109
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Depression - Major Depressive Disorder

Keywords

depression; antidepressant

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4 and 8 of treatment duration

Secondary Outcomes (15)

• Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

  Week 4 and 8 of treatment duration

• Response to treatment

  Week 4 and 8 of treatment duration

• Clinical Global Impression-Severity of Illness (CGI-S)

  Baseline; Week 4 and 8 of treatment duration

• Change from baseline in C-BCT score

  Week 4 and 8 of treatment duration

• Change from baseline in Hamilton Anxiety Rating Scale (HAMA)

  Week 4 and 8 of treatment duration

Study Arms (1)

Escitalopram

EXPERIMENTAL

Participants will receive escitalopram oral solution as open-label monotherapy.

Drug: Escitalopram (Oral antidepressant)

Interventions

Escitalopram (Oral antidepressant) DRUG

Participants will receive escitalopram oral solution as open-label monotherapy.

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University: lead
• The First Hospital of Hebei Medical University: collaborator
• First Hospital of China Medical University: collaborator
• Shandong Mental Health Center: collaborator
• Hebei Provincial Mental Health Center: collaborator

Study Sites (5)

Peking University Sixth Hostipal

Beijing, Beijing Municipality, 100191, China

Location

Hebei Provincial Mental Health Center

Baoding, Hebei, 071000, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shandong Mental Health Center

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram; Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Weihua Yue

CONTACT

86-010-82805307; dryue@bjmu.edu.cn

Tong Yu

CONTACT

86-010-82805307; tongyu@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)