Escitalopram in first-episode, drug-naïve major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, single-arm study will enroll 200 adults aged 18–65 with first-episode major depressive disorder and no recent antidepressant use. Participants will receive escitalopram oxalate oral solution for 8 weeks, with assessments of depressive symptoms, cognitive function, and adverse events at baseline, during treatment, and at week 8. The study also collects clinical, cognitive, laboratory, imaging, genetic, and environmental data to explore mechanisms and identify subgroups that may benefit most from treatment. Blood concentrations of escitalopram will be measured around week 4 to monitor exposure. The goal is to understand efficacy and safety while moving toward precision treatment approaches for depression.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Sixth Hostipal
  Beijing, Beijing Municipality, China Recruiting
• Hebei Provincial Mental Health Center
  Baoding, Hebei, China Recruiting
• The First Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• The First Affiliated Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting
• Shandong Mental Health Center
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Weihua Yue
• Email: dryue@bjmu.edu.cn
• Phone: 86-010-82805307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.