Polycystic Ovary SyndromePhase 4NCT05840692
The Effect of Escitalopram in PCOS
A Phase 4 study testing Escitalopram 20 mg in people with Polycystic Ovary Syndrome, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Escitalopram 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Post menopausal
- Diabetes
- Eating disorder
- Psychiatric disorder
- Usage of oral anticonceptives or metformin
- Pregnancy or planned pregnancy in the treatment period
Show all 9Show fewer
- Non-caucasian
- Epilepsy
- Allergy to the medicine
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Escitalopram 20 mg, Placebo
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 20 mgDrug
Antidepressant
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cipralex | Active comparator | Escitalopram 20 mg x 1 for 12 weeks Receives: Drug: Placebo |
| Placebo | Placebo comparator | Placebo 20 mg x 1 for 12 weeks Receives: Drug: Escitalopram 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenal activity in urine
Cortisol in 24 h urine
Measured: 12 weeks
Adrenal activity during stimulationtest
Cortisol during 60 min ACTH test
Measured: 12 weeks
Secondary outcomes (1)
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)
Glucose
- Muscle and fat biopsy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study startAug 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Marianne Andersen, DMSci, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840692
- Sponsor's protocol ID
- herbert4
- Status last verified
- Apr 2023
- First submitted
- 30 May 2013
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05840692
- Acronym / sponsor ID
- herbert4
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cipralex | Active comparator | Drug: PlaceboEscitalopram 20 mg x 1 for 12 weeks |
| Placebo | Placebo comparator | Drug: Escitalopram 20 mgPlacebo 20 mg x 1 for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Post menopausal
- Diabetes
- Eating disorder
- Psychiatric disorder
- Usage of oral anticonceptives or metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram 20 mgAntidepressant | Drug | Placebo |
| Placebo | Drug | Cipralex |
Primary outcome
Adrenal activity in urine
Time frame: 12 weeks
Cortisol in 24 h urine
Adrenal activity during stimulationtest
Time frame: 12 weeks
Cortisol during 60 min ACTH test
1 secondary outcome
Glucose assesment by 3 hour oral glucose tolerance test (OGTT)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Andersen, DMSci principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram 20 mg in people with Polycystic Ovary Syndrome, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrenal activity in urine (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.