The Effect of Escitalopram in PCOS

The Effect of Anti Depressive Medicine on Adrenal Activity, Glucose Metabolism, Physical and Mental Health in Polycystic Ovary Syndrome. -A Randomised, Double Blinded, Placebo Controlled Study.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05840692

Enrollment

Registered

2023-05-03

Start date

2013-08-31

Completion date

2017-10-31

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Brief summary

In a randomized study the investigators aim to characterize the effect of antidepressive medicine on quality of life, body composition, adrenal activity and glucose metabolism in PCOS. PCOS is a common endocrine disorder characterized by adrenal and ovarian hyperandrogenaemia, anovulation and insulin resistance. The pathogenesis of PCOS may be described by a vicious cycle involving insulin resistance which stimulates ovarian and adrenal hyper androgenaemia and leads to abdominal obesity, causing increased risk for diabetes and cardiovascular disease. Adrenal hyperactivity is associated with depression. Antidepressive medicine may normalize pituitary-adrenal activity and in animal studies antidepressive medicine improved adrenal hyperactivity and normalized insulin sensitivity.

Detailed description

Clinical study Effects of antidepressive treatment on quality of life, insulin sensitivity and cortisone metabolism in PCOS. Hypothesis Participants with PCOS have increased hypothalamic-pituitary-adrenal activity compared to healthy women. Antidepressive treatment improves quality of life, cortisone and glucose turnover. Design A randomized controlled study in 40 PCOS patients who are treated with cipralex or placebo for 12 weeks. Before and after the treatment period the patients have a physical examination, a whole body dexa scan and fasting blood samples. Hypothalamic-pituitary-adrenal is measured by 24 hour samples of cortisone metabolites, 60 minutes ACTH test with basal and stimulated measurement of cortisone and 17-hydroxyprogesterone. Glucose metabolism is examined by oral glucose tolerance test. Biopsies of muscle and fat are also performed.

Interventions

DRUGEscitalopram 20 mg

Antidepressant

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Patients, doctors, alle people involved in analyses

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI \> 25 and \<5 * Age 18-45 years * Two of the following 1: an/oligomenorhea, 2: Hirsutism or hyper androgenaemia, 3: PCO in trans vaginal ultrasound * Other diagnoses excluded

Exclusion criteria

* Post menopausal * Diabetes * Eating disorder * Psychiatric disorder * Usage of oral anticonceptives or metformin * Pregnancy or planned pregnancy in the treatment period * Non-caucasian * Epilepsy * Allergy to the medicine

Design outcomes

Primary

Measure	Time frame	Description
Adrenal activity in urine	12 weeks	Cortisol in 24 h urine
Adrenal activity during stimulationtest	12 weeks	Cortisol during 60 min ACTH test

Secondary

Measure	Time frame	Description
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)	12 weeks	Glucose \- Muscle and fat biopsy

Other

Measure	Time frame	Description
Quality of life, SF36	12 weeks	SF36 \- accelerometer i 7 days
Quality of life, VAS	12 weeks	VAS

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026