Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women (MENO-ES)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Depression - Major Depressive Disorder; General Anxiety Disorder; Therapeutic Drug Monitoring (TDM)

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.

• Study Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: İmran G Yılmaz Karaman, Associate Professor Doctor; Phone Number: 3600 02222392979; Email: imrangokcen.yilmazkaraman@ogu.edu.tr
• Study Contact Backup: Name: Tuğçe Doğan, MD; Phone Number: 3600 02222392979; Email: dogaantugce@gmail.com

Study Locations

• Turkey (Türkiye)
  • Eskişehir, Turkey (Türkiye), 26040
    • Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry
    • Contact: İmran G Yılmaz Karaman, Associate Professor; Phone Number: 3600 00902222392979; Email: imrangokcen.yilmazkaraman@ogu.edu.tr
    • Contact: Tuğçe Doğan, MD; Phone Number: 3600 00902222392979; Email: dogaantugce@gmail.com
    • Principal Investigator: İmran G Yılmaz Karaman, Associate Professor
    • Sub-Investigator: Tuğçe Doğan, MD
    • Sub-Investigator: Aybeniz Civan Kahve, Associate Professor
    • Sub-Investigator: Sinem Kocagil, MD
    • Sub-Investigator: Ali E Altınöz, Professor Doctor
    • Sub-Investigator: Başar Sırmagül, Professor Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Premenopausal Women; Women aged 40-60 years, premenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment.
Postmenopausal Women; Women aged 40-60 years, postmenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 14 days
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.	Up to 14 days
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.	Up to 14 days

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Collaborators: The Scientific and Technological Research Council of Turkey
• Investigators: Principal Investigator: İmran G Yılmaz Karaman, Associtate Professor Doctor, Eskişehir Osmangazi University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: menopause; major depressive disorder; escitalopram; therapeutic drug monitoring; desmethylescitalopram; general anxiety disorder
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major; Generalized Anxiety Disorder
• Other Study ID Numbers: EskisehirOU 09.09.2025/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participants' data will be stored anonymously in an online data repository. IPD will be shared as a study report after data completion is finished.
• IPD Sharing Time Frame: We plan to finish data collection in January 2028, and we plan to publish IPD in 6 months after that.
• IPD Sharing Access Criteria: IPD will be open to the public.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No