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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hebei Provincial Mental Health Center
RECRUITING
Baoding
Peking University Sixth Hostipal
RECRUITING
Beijing
Shandong Mental Health Center
RECRUITING
Jinan
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
Weihua Yue
dryue@bjmu.edu.cn
86-010-82805307
Backup
Tong Yu
tongyu@bjmu.edu.cn
86-010-82805307
Time Frame
Start Date: 2026-03-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Escitalopram
Participants will receive escitalopram oral solution as open-label monotherapy.
Related Therapeutic Areas
Sponsors
Collaborators: Hebei Provincial Mental Health Center, The First Hospital of Hebei Medical University, First Hospital of China Medical University, Shandong Mental Health Center
Leads: Peking University

This content was sourced from clinicaltrials.gov