About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants are women aged 40 to 60 years who have been diagnosed with major depressive disorder and/or generalized anxiety disorder and are currently receiving escitalopram treatment. All participants were recruited from the Psychiatry Clinic of Eskişehir Osmangazi University.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Dose-Related Plasma Escitalopram Concentrations
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
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
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.
Sponsors and contacts
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Eskisehir Osmangazi University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
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