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

January 21, 2021 updated by: University of California, San Francisco

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Center for Reproductive Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Metformin 1000 mg PO bid
Drug: Metformin
Oral medication daily
Other Names:
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Fortamet
Experimental: Vitamin D (Cholecalciferol)
Cholecalciferol 5,000 IU PO daily
Drug: Vitamin D
Oral medication daily
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
Time Frame: 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
Baseline & 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes From Baseline Week in Insulin Resistance Score at Week 12.
Time Frame: 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.
Baseline week & week 12
Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks
Time Frame: 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
Baseline week & Week 12
Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.
Time Frame: 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
Baseline week & week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Heather Huddleston, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2017

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-22550

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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