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NCT Number: NCT07259525

Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women

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.

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Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry

Eskişehir, 26040, Turkey (Türkiye)

Location contact

Ali E Altınöz, Professor Doctor

SUB_INVESTIGATOR

Aybeniz Civan Kahve, Associate Professor

SUB_INVESTIGATOR

Başar Sırmagül, Professor Doctor

SUB_INVESTIGATOR

Sinem Kocagil, MD

SUB_INVESTIGATOR

Tuğçe Doğan, MD

CONTACT

[email protected]

00902222392979 ext. 3600

Tuğçe Doğan, MD

SUB_INVESTIGATOR

İmran G Yılmaz Karaman, Associate Professor

CONTACT

[email protected]

00902222392979 ext. 3600

İmran G Yılmaz Karaman, Associate Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dose-Related Plasma Escitalopram Concentrations

    Time frame: Up to 14 days

    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.

  2. Metabolite to Drug Ratios

    Time frame: Up to 14 days

    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.

  3. Association between plasma S-desmethylescitalopram/escitalopram ratio and serum estradiol levels

    Time frame: Up to 14 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuğçe Doğan, MD

CONTACT

[email protected]

02222392979 ext. 3600

İmran G Yılmaz Karaman, Associate Professor Doctor

CONTACT

[email protected]

02222392979 ext. 3600

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Acronym: MENO-ES

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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