Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Dose-Related Plasma Escitalopram Concentrations
研究概览
简要总结
This observational cross-sectional case-control study aims to evaluate the effects of menopausal status on escitalopram metabolism in women. The study will include premenopausal and menopausal women aged 40-60 years who are currently receiving escitalopram treatment and have applied to the Psychiatry Clinic of Eskişehir Osmangazi University. The study aims to identify pharmacokinetic differences associated with hormonal status and to investigate their potential clinical implications. Findings from this research are expected to contribute to the development of evidence-based, individualized treatment strategies for women in menopausal transition.
详细描述
Participants' plasma escitalopram and desmethylescitalopram levels, mental disorder severity, anthropometric measurements, bioimpedance, CYP2C19 genotype analysis, estradiol and follicle-stimulating hormone (FSH) levels, and corrected QT interval (QTc) length will be assessed. In the preliminary analysis, participants carrying the CYP2C19*1 allele will be selected from the data of 78 participants for comparative analyses. Those with the dominant allele will be selected for final analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 40 years or older and 60 years or younger
- •Diagnosed with major depressive disorder and/or generalized anxiety disorder by an independent psychiatrist (not a member of the research team)
- •Prescribed escitalopram treatment by an independent psychiatrist (not a member of the research team)
- •Receiving escitalopram treatment for at least one month and on a stable dose for at least one week
- •Willing to participate in the study and provide informed consent
- •Additional inclusion criterion for the menopausal group: Amenorrhea for at least one year (consistent with menopause diagnosis)
- •Additional inclusion criteria for the premenopausal group: Having regular menstrual cycles and being in the luteal phase (within 14 days after ovulation) of the menstrual cycle
排除标准
- •Diagnosis of intellectual disability, dementia, psychotic disorders, schizoaffective disorder, or bipolar disorder
- •Alcohol or substance use disorder
- •Diagnosis of hepatic failure, renal failure, or cardiac failure
- •Severe malnutrition
- •Presence of an active systemic infectious or inflammatory disease
- •Current use of hormone replacement therapy for menopause
- •Use of oral contraceptives
- •Pregnancy or breastfeeding
- •Use of medications known to affect escitalopram plasma concentration
- •Use of medications that affect the CYP2C19 enzyme
- •Detection of alleles other than the predominant CYP2C19*1 genotype in genetic analyses
结局指标
主要结局
Dose-Related Plasma Escitalopram Concentrations
时间窗: Up to 14 days
Plasma escitalopram concentrations will be measured in participants using therapeutic drug monitoring methods. The primary objective is to compare dose-related plasma escitalopram concentrations between premenopausal and menopausal women receiving escitalopram treatment.
Metabolite to Drug Ratios
时间窗: Up to 14 days
Plasma escitalopram and desmethylescitalopram concentrations will be measured in participants using therapeutic drug monitoring methods. The primary objective of the study is to evaluate differences in drug metabolism by comparing metabolite-to-parent drug ratios between premenopausal and menopausal women receiving escitalopram.
Association between plasma S-desmethylescitalopram/escitalopram ratio and serum estradiol levels
时间窗: Up to 14 days
The primary outcome is the evaluation of the relationship between the plasma S-desmethylescitalopram/escitalopram metabolite-to-parent drug ratio and serum estradiol concentrations in all participants. The study will test whether lower estradiol levels are associated with higher metabolite-to-drug ratios.
次要结局
未报告次要终点
研究者
Imran Gokcen Yilmaz-Karaman
Associate professor doctor
Eskisehir Osmangazi University