Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry
Eskişehir, 26040, Turkey (Türkiye)
NCT Number: NCT07259525
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.
Trial opening soon.
Get Notified40 year–60 year
Female
Observational
Eskişehir, 26040, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Trial opening soon.
Get NotifiedEskisehir Osmangazi University
Other
Acronym: MENO-ES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07607288
Actinomycetales Infections, Bacterial Infections
Beijing, Beijing Municipality, China
View Trial DetailsNCT07477119
Actinomycetales Infections, Bacterial Infections
Conakry, Guinea
View Trial DetailsNCT07487714
Arrhythmias, Cardiac, Atrial Fibrillation
Tomsk, Russia
View Trial DetailsNCT06596811
AKI, Therapeutic Drug Monitoring (TDM)
Jinan, China
View Trial Details