Trials / Not Yet Recruiting
Not Yet RecruitingNCT07259525
Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 94 (estimated)
- Sponsor
- Eskisehir Osmangazi University · Academic / Other
- Sex
- Female
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Therapeutic Drug Monitoring (TDM)
- Menopause
- Depression - Major Depressive Disorder
- General Anxiety Disorder
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2028-01-01
- Completion
- 2028-06-01
- First posted
- 2025-12-02
- Last updated
- 2025-12-22
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07259525. Inclusion in this directory is not an endorsement.