NCT03380091

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• PCOS
• Depression
• Vitamin D Deficiency
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Metformin	Oral medication daily
DRUG	Vitamin D	Oral medication daily

Timeline

• Start date: 2017-12-12
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-12-20
• Last updated: 2021-02-09
• Results posted: 2021-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study