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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adrenal activity during stimulationtest
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients, doctors, alle people involved in analyses
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Post menopausal
- •Eating disorder
- •Psychiatric disorder
- •Usage of oral anticonceptives or metformin
- •Pregnancy or planned pregnancy in the treatment period
- •Non-caucasian
- •Allergy to the medicine
研究组 & 干预措施
Cipralex
Escitalopram 20 mg x 1 for 12 weeks
干预措施: Placebo (Drug)
Placebo
Placebo 20 mg x 1 for 12 weeks
干预措施: Escitalopram 20 mg (Drug)
结局指标
主要结局
Adrenal activity during stimulationtest
时间窗: 12 weeks
Cortisol during 60 min ACTH test
Adrenal activity in urine
时间窗: 12 weeks
Cortisol in 24 h urine
次要结局
- Glucose assesment by 3 hour oral glucose tolerance test (OGTT)(12 weeks)
研究者
Marianne Andersen
Clinical professor, MD
Odense University Hospital