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

Phase 4TerminatedNCT03380091

University of California, San Francisco5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PCOS Depression Vitamin D Deficiency Insulin Resistance

Interventions

MetforminDRUG

Oral medication daily

Vitamin DDRUG

Oral medication daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCSF Center for Reproductive Health

San Francisco, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 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

Time frame: Baseline & 12 weeks

Secondary Outcomes

Changes From Baseline Week in Insulin Resistance Score at 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.

Time frame: Baseline week & week 12

Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks

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

Time frame: Baseline week & Week 12

Changes From Baseline Week in Vitamin D 25-hydroxy Levels at 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

Time frame: Baseline week & week 12

Data from ClinicalTrials.gov

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