Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-60
SponsorEskisehir Osmangazi University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

94 Participants
are grouped into 2 trial groups
Group A: Premenopausal Women
Group B: Postmenopausal Women

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 14 days
2

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.

Time frame
Up to 14 days
3

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.

Time frame
Up to 14 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eskisehir Osmangazi University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator

This trial is not recruiting at the moment. You can still explore other options: