The Effect of Escitalopram in PCOS
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.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedMay 3, 2023
April 1, 2023
4.2 years
May 30, 2013
April 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Adrenal activity in urine
Cortisol in 24 h urine
12 weeks
Adrenal activity during stimulationtest
Cortisol during 60 min ACTH test
12 weeks
Secondary Outcomes (1)
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)
12 weeks
Other Outcomes (2)
Quality of life, SF36
12 weeks
Quality of life, VAS
12 weeks
Study Arms (2)
Cipralex
ACTIVE COMPARATOREscitalopram 20 mg x 1 for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo 20 mg x 1 for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense Universitetshospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Andersen, DMSci
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Patients, doctors, alle people involved in analyses
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor, MD
Study Record Dates
First Submitted
May 30, 2013
First Posted
May 3, 2023
Study Start
August 1, 2013
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
May 3, 2023
Record last verified: 2023-04