Therapeutic Drug Monitoring (TDM)MENO-ESNCT07259525
Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
An observational study of Therapeutic Drug Monitoring (TDM) and Menopause, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Therapeutic Drug Monitoring (TDM), Menopause, Depression - Major Depressive Disorder
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2026to Jun 2028
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants are women aged 40 to 60 years who have been diagnosed with major depressive disorder and/or generalized anxiety disorder and are currently receiving escitalopram treatment. All participants were recruited from the Psychiatry Clinic of Eskişehir Osmangazi University.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
İmran G Yılmaz Karaman, Associate Professor Doctor contact
Turkey (Türkiye)1 site
Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry
Eskişehir, 26040
İmran G Yılmaz Karaman, Associate Professor, 00902222392979 ext. 3600, imrangokcen.yilmazkaraman@ogu.edu.tr
Tuğçe Doğan, MD, 00902222392979 ext. 3600, dogaantugce@gmail.com
About this study
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.
Read the 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.
- Conditions
- Therapeutic Drug Monitoring (TDM), Menopause, Depression - Major Depressive Disorder, General Anxiety Disorder
- Keywords
- escitalopram, desmethylescitalopram, menopause, therapeutic drug monitoring, major depressive disorder, general anxiety disorder
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Women | Women aged 40-60 years, premenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment. | |
| Postmenopausal Women | Women aged 40-60 years, postmenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Related Plasma Escitalopram Concentrations
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.
Measured: Up to 14 days
Metabolite to Drug Ratios
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.
Measured: Up to 14 days
Association between plasma S-desmethylescitalopram/escitalopram ratio and serum estradiol levels
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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Drug Monitoring (TDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Imran Gokcen Yilmaz-Karaman, Eskisehir Osmangazi University
- Investigators
- İmran G Yılmaz Karaman, Associtate Professor Doctor, Principal investigator, Eskişehir Osmangazi University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259525
- Sponsor's protocol ID
- EskisehirOU 09.09.2025/22
- Acronym
- MENO-ES
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' data will be stored anonymously in an online data repository. IPD will be shared as a study report after data completion is finished.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07259525
- Acronym / sponsor ID
- MENO-ES / EskisehirOU 09.09.2025/22
- Conditions
- Therapeutic Drug Monitoring (TDM), Menopause, Depression - Major Depressive Disorder, General Anxiety Disorder
- Keywords
- escitalopram, desmethylescitalopram, menopause, therapeutic drug monitoring, major depressive disorder, general anxiety disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Women | – | –Women aged 40-60 years, premenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment. |
| Postmenopausal Women | – | –Women aged 40-60 years, postmenopausal, diagnosed with major depressive disorder and/or generalized anxiety disorder, and currently receiving escitalopram treatment. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants are women aged 40 to 60 years who have been diagnosed with major depressive disorder and/or generalized anxiety disorder and are currently receiving escitalopram treatment. All participants were recruited from the Psychiatry Clinic of Eskişehir Osmangazi University.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dose-Related Plasma Escitalopram Concentrations
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Participants' data will be stored anonymously in an online data repository. IPD will be shared as a study report after data completion is finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
İmran G Yılmaz Karaman, Associate Professor Doctor contact
İmran G Yılmaz Karaman, Associtate Professor Doctor principal investigator
Eskişehir Osmangazi University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Drug Monitoring (TDM) and Menopause, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İmran G Yılmaz Karaman, Associate Professor Doctor (02222392979 ext. 3600, imrangokcen.yilmazkaraman@ogu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Related Plasma Escitalopram Concentrations (time frame: Up to 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.