The Effect of Escitalopram in PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Escitalopram 20 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
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
Sites / Locations
- Odense Universitetshospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cipralex
Placebo
Arm Description
Escitalopram 20 mg x 1 for 12 weeks
Placebo 20 mg x 1 for 12 weeks
Outcomes
Primary Outcome Measures
Adrenal activity in urine
Cortisol in 24 h urine
Adrenal activity during stimulationtest
Cortisol during 60 min ACTH test
Secondary Outcome Measures
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)
Glucose
- Muscle and fat biopsy
Full Information
NCT ID
NCT05840692
First Posted
May 30, 2013
Last Updated
April 24, 2023
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05840692
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients, doctors, alle people involved in analyses
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cipralex
Arm Type
Active Comparator
Arm Description
Escitalopram 20 mg x 1 for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 20 mg x 1 for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram 20 mg
Intervention Description
Antidepressant
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Adrenal activity in urine
Description
Cortisol in 24 h urine
Time Frame
12 weeks
Title
Adrenal activity during stimulationtest
Description
Cortisol during 60 min ACTH test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)
Description
Glucose
- Muscle and fat biopsy
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life, SF36
Description
SF36
- accelerometer i 7 days
Time Frame
12 weeks
Title
Quality of life, VAS
Description
VAS
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Andersen, DMSci
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Escitalopram in PCOS
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