Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
研究概览
简要总结
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
详细描述
This is a single center, open-label, randomized, pilot clinical trial. Women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin D insufficient are eligible. Subjects are randomly assigned to one of two interventions: Vitamin D versus metformin. Subjects are followed with questionnaires and a final wrap-up clinic visit with a physician. The study duration is 12 weeks.
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
- None
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
- •Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
- •Vitamin D insufficiency (serum Vitamin D <30 ng/mL)
- •Insulin resistance
- •Mild or greater severity of depression by Beck Depression Inventory-II
排除标准
- •Current metformin use
- •Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency
- •Insulin-dependent diabetes mellitus
- •Pregnancy or breastfeeding
- •Untreated hypothyroidism
- •Current active substance abuse
- •Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
研究组 & 干预措施
Metformin
Metformin 1000 mg PO bid
干预措施: Metformin (Drug)
Vitamin D (Cholecalciferol)
Cholecalciferol 5,000 IU PO daily
干预措施: Vitamin D (Drug)
结局指标
主要结局
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
时间窗: Baseline & 12 weeks
BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score
次要结局
- Changes From Baseline Week in Insulin Resistance Score at Week 12.(Baseline week & week 12)
- Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks(Baseline week & Week 12)
- Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.(Baseline week & week 12)