Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women (NCT07259525) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
Turkey (Türkiye)94 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
40 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-Related Plasma Escitalopram Concentrations
Timeframe: Up to 14 days
2
Metabolite to Drug Ratios
Timeframe: Up to 14 days
3
Association between plasma S-desmethylescitalopram/escitalopram ratio and serum estradiol levels
Timeframe: Up to 14 days
Trial details
NCT IDNCT07259525
SponsorEskisehir Osmangazi University
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2028-01
Contact for this trial
İmran G Yılmaz Karaman, Associate Professor Doctor