The Effect of Escitalopram in PCOS

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05840692

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Escitalopram 20 mg Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Patients, doctors, alle people involved in analyses

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cipralex Escitalopram 20 mg x 1 for 12 weeks	Drug: Placebo
Placebo Comparator: Placebo Placebo 20 mg x 1 for 12 weeks	Drug: Escitalopram 20 mg Antidepressant

Arm

Intervention/Treatment

Active Comparator: Cipralex

Escitalopram 20 mg x 1 for 12 weeks

Drug: Placebo

Placebo Comparator: Placebo

Placebo 20 mg x 1 for 12 weeks

Drug: Escitalopram 20 mg

Antidepressant

Outcome Measures

Primary Outcome Measures

Adrenal activity in urine [12 weeks]
Cortisol in 24 h urine
Adrenal activity during stimulationtest [12 weeks]
Cortisol during 60 min ACTH test

Secondary Outcome Measures

Glucose assesment by 3 hour oral glucose tolerance test (OGTT) [12 weeks]
Glucose - Muscle and fat biopsy

Other Outcome Measures

Quality of life, SF36 [12 weeks]
SF36 - accelerometer i 7 days
Quality of life, VAS [12 weeks]
VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense Universitetshospital	Odense		Denmark	5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator: Marianne Andersen, DMSci, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marianne Andersen, Clinical professor, MD, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT05840692

Other Study ID Numbers:

herbert4

First Posted:

May 3, 2023

Last Update Posted:

May 3, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Citalopram

Study Results

No Results Posted as of May 3, 2023