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Completed

NCT Number: NCT05840692

The Effect of Escitalopram in PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Odense Universitetshospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram 20 mg

Drug

Antidepressant

Placebo

Drug

Primary outcomes

  1. Adrenal activity in urine

    Time frame: 12 weeks

    Cortisol in 24 h urine

  2. Adrenal activity during stimulationtest

    Time frame: 12 weeks

    Cortisol during 60 min ACTH test

Secondary outcomes

  1. Glucose assesment by 3 hour oral glucose tolerance test (OGTT)

    Time frame: 12 weeks

    Glucose

    • Muscle and fat biopsy

Other outcomes

  1. Quality of life, SF36

    Time frame: 12 weeks

    SF36

    • accelerometer i 7 days

  2. Quality of life, VAS

    Time frame: 12 weeks

    VAS

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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