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

Depression Clinical Trial

— MINDD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03380091
• Other study ID #: 17-22550
• Status: Terminated
• Phase: Phase 4
• Start date: December 12, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insulin Resistance
• PCOS
• Polycystic Ovary Syndrome
• Vitamin D Deficiency

Intervention

Drug:
• Metformin
Oral medication daily
• Vitamin D
Oral medication daily

Locations

Country	Name	City	State
United States	UCSF Center for Reproductive Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline & 12 weeks
Secondary	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.	Baseline week & week 12
Secondary	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	Baseline week & Week 12
Secondary	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	Baseline week & week 12