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

Обзор

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.

Вмешательства

• Препарат Escitalopram (Oral antidepressant)
  Participants will receive escitalopram oral solution as open-label monotherapy.

Первичные конечные точки

• Change from baseline in Hamilton Depression Rating Scale (HAMD) [Срок оценки: Week 4 and 8 of treatment duration]

Вторичные конечные точки (12)

• Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: Week 4 and 8 of treatment duration]
• Response to treatment [Срок оценки: Week 4 and 8 of treatment duration]
• Clinical Global Impression-Severity of Illness (CGI-S) [Срок оценки: Baseline; Week 4 and 8 of treatment duration]
• Change from baseline in C-BCT score [Срок оценки: Week 4 and 8 of treatment duration]
• Change from baseline in Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: Week 4 and 8 of treatment duration]
• Treatment Emergent Symptom Scale (TESS) [Срок оценки: Baseline; Week 4 and 8 of treatment duration]
• Escitalopram Therapeutic drug monitoring [Срок оценки: Week 4 of treatment duration]
• Change from baseline in Snaith-Hamilton Pleasure Scale (SHAPS) [Срок оценки: Week 4 and 8 of treatment duration]
• The Temporal Experience of Pleasure Scale (TEPS) [Срок оценки: Week 4 and 8 of treatment duration]
• Childhood Trauma Questionnaire (CTQ) [Срок оценки: Baseline]
• Change from baseline in Ruminative Responses Scale (RRS) [Срок оценки: Week 4 and 8 of treatment duration]
• Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Week 4 and 8 of treatment duration]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Peking University Sixth Hostipal — Пекин
• Hebei Provincial Mental Health Center — Baoding
• The First Hospital of Hebei Medical University — Shijiazhuang
• The First Affiliated Hospital of China Medical University — Шэньян
• Shandong Mental Health Center — Цзинань

Идентификаторы

NCT: NCT07480525 · 2025-109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗