Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women

NCT07259525 | Not Yet Recruiting

• 1 other identifier: EskisehirOU 09.09.2025/22
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Therapeutic Drug Monitoring (TDM); Menopause; Depression - Major Depressive Disorder; General Anxiety Disorder

Keywords

escitalopram; desmethylescitalopram; menopause; therapeutic drug monitoring; major depressive disorder; general anxiety disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Eligibility is restricted to participants assigned female at birth, as the study focuses on premenopausal and menopausal physiological status.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry

Eskişehir, 26040, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• İmran G Yılmaz Karaman, Associtate Professor Doctor

  Eskişehir Osmangazi University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İmran G Yılmaz Karaman, Associate Professor Doctor

CONTACT

02222392979; imrangokcen.yilmazkaraman@ogu.edu.tr

Tuğçe Doğan, MD

CONTACT

02222392979; dogaantugce@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor doctor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: We plan to finish data collection in January 2028, and we plan to publish IPD in 6 months after that.
• Access Criteria: IPD will be open to the public.

Locations

TU (1)