Clinical trial NCT05840692: The Effect of Escitalopram in PCOS
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adrenal activity in urine
timeFrame: 12 weeks
measure: Adrenal activity during stimulationtest
timeFrame: 12 weeks
Secondary outcomes:
measure: Glucose assesment by 3 hour oral glucose tolerance test (OGTT)
timeFrame: 12 weeks
Other outcomes:
measure: Quality of life, SF36
timeFrame: 12 weeks
measure: Quality of life, VAS
timeFrame: 12 weeks
Locations:
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
affiliation: Odense University Hospital
name: Marianne Andersen, DMSci
role: PRINCIPAL_INVESTIGATOR
References: