Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380091
Recruitment Status : Terminated (Recruitment challenges)
First Posted : December 20, 2017
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
PCOS Depression Vitamin D Deficiency Insulin Resistance Drug: Metformin Drug: Vitamin D Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019


Arm Intervention/treatment
Experimental: Metformin
Metformin 1000 mg PO bid
Drug: Metformin
Oral medication daily
Other Names:
  • Glucophage
  • Glucophage XR
  • Fortamet
  • Glumetza

Experimental: Vitamin D (Cholecalciferol)
Cholecalciferol 5,000 IU PO daily
Drug: Vitamin D
Oral medication daily
Other Name: Cholecalciferol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380091


Locations
Layout table for location information
United States, California
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Heather Huddleston, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03380091    
Other Study ID Numbers: 17-22550
First Posted: December 20, 2017    Key Record Dates
Results First Posted: February 9, 2021
Last Update Posted: February 9, 2021
Last Verified: January 2021

Layout table for additional information
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
Keywords provided by University of California, San Francisco:
PCOS
Depression
Vitamin D
Insulin Resistance
Anxiety
Quality of life
Mood disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Insulin Resistance
Vitamin D Deficiency
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Metformin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs