Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial

Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial

Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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