Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Other Indications, Women's Studies, Endocrine, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Psychiatry / Psychology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/7/2019 |
| Start Date: | December 12, 2017 |
| End Date: | April 2021 |
| Contact: | Eleni A Greenwood, MD |
| Email: | eleni.greenwood@ucsf.edu |
| Phone: | (415) 353-7475 |
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.
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.
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
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