The Effect of Escitalopram in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840692
• Other study ID #: herbert4
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: October 2017

Study information

• Verified date: April 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Escitalopram 20 mg
Antidepressant
• Placebo

Locations

Country	Name	City	State
Denmark	Odense Universitetshospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life, SF36	SF36; - accelerometer i 7 days	12 weeks
Other	Quality of life, VAS	VAS	12 weeks
Primary	Adrenal activity in urine	Cortisol in 24 h urine	12 weeks
Primary	Adrenal activity during stimulationtest	Cortisol during 60 min ACTH test	12 weeks
Secondary	Glucose assesment by 3 hour oral glucose tolerance test (OGTT)	Glucose; - Muscle and fat biopsy	12 weeks