NCT07259525Not yet recruiting
Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 94 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- Jan 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Eskisehir Osmangazi University
- Diseases
- Depression
- NCT number
- NCT07259525
What you commit to
- Study type: Observational
- Planned participants: 94
- From Jan 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of hormone replacement therapy for menopause
- Use of medications known to affect escitalopram plasma concentration
- Use of medications that affect the CYP2C19 enzyme
Other illness
- 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
- Presence of an active systemic infectious or inflammatory disease
Other
- Severe malnutrition
- Use of oral contraceptives
- Pregnancy or breastfeeding
- Detection of alleles other than the predominant CYP2C19\*1 genotype in genetic analyses
Who the study is looking for
- 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
Age in the registry: 40 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.