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Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women

NCT ID: NCT07259525

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-06-30

Brief Summary

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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

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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

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

Keywords

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escitalopram desmethylescitalopram menopause therapeutic drug monitoring major depressive disorder general anxiety disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Premenopausal Women

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

No interventions assigned to this group

Postmenopausal Women

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

No interventions assigned to this group

Eligibility Criteria

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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)

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Imran Gokcen Yilmaz-Karaman

Associate professor doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İmran G Yılmaz Karaman, Associtate Professor Doctor

Role: PRINCIPAL_INVESTIGATOR

Eskişehir Osmangazi University, Faculty of Medicine

Locations

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Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry

Eskişehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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İmran G Yılmaz Karaman, Associate Professor Doctor

Role: CONTACT

Phone: 02222392979

Email: [email protected]

Tuğçe Doğan, MD

Role: CONTACT

Phone: 02222392979

Email: [email protected]

Facility Contacts

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İmran G Yılmaz Karaman, Associate Professor

Role: primary

Tuğçe Doğan, MD

Role: backup

Other Identifiers

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EskisehirOU 09.09.2025/22

Identifier Type: -

Identifier Source: org_study_id