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

Phase 4

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Vitamin D (Cholecalciferol)	Vitamin D	Cholecalciferol 5,000 IU PO daily
Metformin	Metformin	Metformin 1000 mg PO bid

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks	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

Secondary Outcome Measures

Name	Time	Method
Changes From Baseline Week in Insulin Resistance Score at Week 12.	Baseline week & week 12	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.
Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks	Baseline week & Week 12	STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score
Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.	Baseline week & week 12	Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated. Reference ranges: optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL