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

Eskisehir Osmangazi University

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07259525

EskisehirOU 09.09.2025/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

94 participants in 2 patient groups

Premenopausal Women

Description:

Women aged 40-60 years, premenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment.

Postmenopausal Women

Description:

Women aged 40-60 years, postmenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment.