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Not yet recruiting NCT07259525

Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Therapeutic Drug Monitoring (TDM), Menopause, Depression - Major Depressive Disorder, General Anxiety Disorder. Basic parameters: 40 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Primary outcome measures

  • Dose-Related Plasma Escitalopram Concentrations [Time frame: Up to 14 days]
  • Metabolite to Drug Ratios [Time frame: Up to 14 days]
  • Association between plasma S-desmethylescitalopram/escitalopram ratio and serum estradiol levels [Time frame: Up to 14 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry — Eskişehir

Identifiers

NCT: NCT07259525 · EskisehirOU 09.09.2025/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗