Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-26 @ 6:02 PM
Study NCT ID:
NCT05840692
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Escitalopram in PCOS
Sponsor:
Odense University Hospital
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: