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

NCT03380091 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-22550
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; Depression; Vitamin D Deficiency; Insulin Resistance

Keywords

PCOS; Depression; Vitamin D; Insulin Resistance; Anxiety; Quality of life; Mood disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes From Baseline Week in Insulin Resistance Score at Week 12.

  Baseline week & week 12

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

  Baseline week & Week 12

• Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.

  Baseline week & week 12

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin 1000 mg PO bid

Drug: Metformin

Vitamin D (Cholecalciferol)

EXPERIMENTAL

Cholecalciferol 5,000 IU PO daily

Drug: Vitamin D

Interventions

Metformin DRUG

Oral medication daily

Also known as: Glucophage, Glucophage XR, Fortamet, Glumetza

Metformin

Vitamin D DRUG

Oral medication daily

Also known as: Cholecalciferol

Vitamin D (Cholecalciferol)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Center for Reproductive Health

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Depression; Vitamin D Deficiency; Insulin Resistance; Anxiety Disorders; Mood Disorders

Interventions

Metformin; Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Limitations and Caveats

Feasibility of recruitment and participant completion determined to be too low to continue the study and the trial was terminated early, resulting in only 2 of the 5 enrolled participants completing the trial. This lead to only two subjects will full data and one subject with partial data being analyzed.

Results Point of Contact

• Title: Heather Huddleston
• Organization: University of California, San Francisco

Heather.Huddleston@ucsf.edu

(415) 353-3040

Study Officials

• Heather Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: December 12, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Locations

US (1)