Depression - Major Depressive Disorder, General Anxiety Disorder, Menopause, Therapeutic Drug Monitoring (TDM)
Conditions
Keywords
escitalopram, desmethylescitalopram, menopause, therapeutic drug monitoring, major depressive disorder, general anxiety disorder
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.
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.
Interventions
None listed
Sponsors
The Scientific and Technological Research Council of Turkey
Eskisehir Osmangazi University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Related Plasma Escitalopram Concentrations | 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. |
| Metabolite to Drug Ratios | 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. |
| Association between plasma S-desmethylescitalopram/escitalopram ratio and serum estradiol levels | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactİmran G Yılmaz Karaman, Associate Professor Doctor
Backup ContactTuğçe Doğan, MD
Outcome results
None listed