The Effect of Escitalopram in PCOS

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Escitalopram 20 mg; Drug: Placebo

• Registration Number: NCT05840692
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study First Submitted: 2013-05-30
• Study Start: 2013-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Escitalopram 20 mg	Placebo 20 mg x 1 for 12 weeks
Cipralex	Placebo	Escitalopram 20 mg x 1 for 12 weeks

Primary Outcome Measures

Name	Time	Method
Adrenal activity during stimulationtest	12 weeks	Cortisol during 60 min ACTH test
Adrenal activity in urine	12 weeks	Cortisol in 24 h urine

Secondary Outcome Measures

Name	Time	Method
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)	12 weeks	Glucose; - Muscle and fat biopsy

Trial Locations

Locations (1)

Odense Universitetshospital; 🇩🇰 Odense, Denmark