NCT07480525

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Escitalopram (Oral antidepressant)	Participants will receive escitalopram oral solution as open-label monotherapy.

Timeline

• Start date: 2026-03-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

5 sites across 1 country: China